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A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria. (REVISIT)

Primary Purpose

Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ATM-AVI
MTZ
MER
COL
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Intra-abdominal Infection focused on measuring Complicated intra-abdominal infection, Hosptial acquired pneumonia, Ventilator associated pneumonia, Gram negative infections, Metallo-beta lactamase, Multi drug resistant pathogens

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All subjects:

  1. Male or female from 18 years of age
  2. Provision of informed consent
  3. Confirmed diagnosis of HAP/VAP or cIAI requiring iv antibiotic treatment
  4. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met and negative pregnancy test

Additional for cIAI:

  1. Diagnosis of cIAI, EITHER:

    Intra-operative/postoperative enrolment with visual confirmation of cIAI. OR Preoperative enrollment with evidence of systemic inflammatory response, physical and radiological findings consistent with cIAI; confirmation of cIAI at time of surgery within 24 hours of study entry

  2. Surgical intervention within 24 hours (before or after) the administration of the first dose of study drug

Additional for HAP/VAP:

  1. Onset symptoms > 48h after admission to or <7 days after discharge from an inpatient care facility
  2. New or worsening infiltrate on CXR or CT scan
  3. Clinical signs and symptoms and laboratory findings consistent with HAP/VAP
  4. Respiratory specimen obtained for Gram stain and culture following onset of symptoms and prior to randomisation

Exclusion criteria:

All subjects:

  1. APACHE II score > 30
  2. Confirmed or suspected infection caused by Gram-negative species not expected to respond to study drug, or Gram-positive species
  3. Receipt of >24 hr systemic antibiotic within 48h prior to randomisation (exception in case of treatment failure)
  4. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other β-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs
  5. Known Clostridium difficle associated diarrhoea
  6. Requirement for effective concomitant systemic antibacterials or antifungals
  7. Creatinine clearance ≤15 ml/min or requirement or expectation for renal replacement therapy
  8. Acute hepatitis, cirrhosis, acute hepatic failure, chronic hepatic failure
  9. Hepatic disease as indicated by AST or ALT >3 × ULN. Patients with AST and/or ALT up to 5 × ULN are eligible if acute and documented by the investigator as being directly related infectious process
  10. Patient has a total bilirubin >2 × ULN, unless isolated hyperbilirubinemia is directly related to infectious process or due to known Gilbert's disease
  11. ALP >3 × ULN. Patients with values >3 × ULN and <5 x ULN are eligible if acute and directly related to the infectious process being treated
  12. Absolute neutrophil count <500/mm3
  13. Pregnant or breastfeeding or if of child bearing potential, not using a medically accepted effective method of birth control.
  14. Any other condition that may confound the results of the study or pose additional risks to the subject
  15. Unlikely to comply with protocol
  16. History of epilepsy or seizure disorders excluding febrile seizures of childhood

Additional for cIAI

  1. Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery < 24 hours of diagnosis primary etiology is not likely to be infectious
  2. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess
  3. Prior liver, pancreas or small-bowel transplant
  4. Staged abdominal repair (STAR), open abdomen technique or marsupialisation

Additional for HAP/VAP

  1. APACHE II score < 10
  2. Known or high likelihood of Gram-positive monomicrobial infection
  3. Lung abscess, pleural empyema, post-obstructive pneumonia
  4. Lung or heart transplant
  5. Myasthenia gravis

Sites / Locations

  • Banner University Medical Center - Tucson
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Harbor-UCLA Medical Center
  • Southern Illinois University School of Medicine
  • Memorial Medical Center
  • Sanatorio Britanico
  • Sanatorio Servicios Medicos SM
  • Hospital San Roque
  • University Hospital Alexandrovska, Clinic of Anesthesiology and Intensive Care
  • University Hospital Queen Joanna ISUL, Clinic of Surgery
  • University Multiprofile Hospital for Active Treatment ''Prof.Dr Stoyan Kirkovich''AD
  • Peking University Third Hospital
  • Zhangzhou Municipal Hospital of Fujian Province
  • ZhuJiang Hospital of Southern Medical University
  • The First Affiliated Hospital of Shantou University Medical College
  • The Second People's Hospital of Shenzhen
  • Nanning First People's Hospital
  • Affiliated Hospital of Guilin Medical University
  • Changsha Third Hospital
  • Hunan Province People's Hospital
  • Baotou Central Hospital
  • Jiangyin People's Hospital
  • Affiliated Hospital of Jiangsu University
  • Huashan Hospital Fudan University
  • Shanghai Pulmonary Hospital
  • The First people's Hospital of Kunming
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Taizhou Hospital of Zhejiang Province
  • Lishui People's Hospital
  • Quzhou People's Hospital
  • Peking University People's Hospital
  • Jiangyin People's Hospital
  • Tianjin Union Medical Center
  • Klinicka bolnica Merkur
  • Klinicki bolnicki centar Rijeka
  • University Hospital Centre Osijek
  • General Hospital "Dr. Josip Bencevic" Slavonski Brod
  • Clinical Hospital Dubrava
  • Fakultni nemocnice Brno
  • Krajska zdravotni, a.s. - Nemocnice Decin, o.z.
  • Lekarna Nemocnice Decin, Krajska zdravotni, a.s.- Nemocnice Decin, o.z.
  • Public Hospital Kolin, a.s.
  • Nemocnice Kyjov, prispevkova organizace
  • Fakultni nemocnice Kralovske Vinohrady
  • General Hospital of Athens "Evangelismos"
  • General and Chest Diseases Hospital "Sotiria"
  • General Hospital of Athens "Laiko"
  • University General Hospital "ATTIKON"
  • University General Hospital of Heraklion
  • University General Hospital of Larissa
  • Koutlimbaneio and Triantafylleio General Hospital of Larissa
  • King George Hospital
  • Victoria Hospital, Bangalore Medical College and Research Institute
  • M S Ramaiah Medical College and Hospitals
  • Kasturba Medical College and Hospital
  • JSS Hospital
  • Amrita Institute of Medical Sciences & Research Centre
  • Government Medical College, Kozhikode
  • Deenanath Mangeshkar Hospital And Research Centre
  • Sahyadri Super Speciality Hospital
  • Sahyadri Super Specialty Hospital
  • S.R. Kalla Memorial Gastro & General Hospital
  • Apollo Hospitals
  • King George's Medical University
  • Dayanand Medical College and Hospital
  • Sahyadri Clinical Research & Development Center
  • Sahyadri Specialty Hospital
  • Assuta Ashdod University Hospital
  • Rambam Health Care Campus
  • Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
  • Rabin Medical Center, Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • The Chaim Sheba Medical Center
  • Shamir Medical Center, Infectious Diseases Unit
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliero-Universitaria Ospedali Riuniti
  • Azienda Ospedaliero Universitaria di Modena
  • Farmacia Ospedaliera - Direzione Assistenza Farmaceutica
  • SC di Radiologia - Azienda Ospedaliera Universitaria di Modena
  • Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
  • UO Radiognastostica 2 Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
  • UO Farmaceutica Azienda Ospedaliero-Universitaria Pisana
  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa
  • Gachon University Gil Medical Center - Infectious Disease
  • Seoul National University Hospital
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Hallym University Kangnam Sacred Heart Hospital
  • Hospital Seberang Jaya
  • Hospital Sultanah Nur Zahirah
  • University Malaya Medical Centre
  • Hospital Civil Fray Antonio Alcalde
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • De La Salle Medical and Health Sciences Institute
  • Baguio General Hospital and Medical Center
  • Davao Doctors Hospital
  • St. Paul's Hospital of Iloilo, Inc.
  • West Visayas State University Medical Center
  • Makati Medical Center
  • Philippine General Hospital, Central Intensive Care Unit
  • Asian Hospital and Medical Center
  • Quirino Memorial Medical Center
  • St. Luke's Medical Center
  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
  • Spitalul Clinic de Boli Infectioase si tropicale "Dr. Victor Babes"
  • Spitalul Clinic de Boli Infectioase Cluj-Napoca
  • Spitalul Clinic de Boli Infectioase "Sf. Parascheva" Iasi
  • Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
  • Private Healthcare Institution "Clinical Hospital 'Russian Railroad Medicine, Chelyabinsk'"
  • State Budgetary Healthcare Institution "Regional Clinical Hospital No. 2" of the Ministry of Health
  • GBUZ of Novosibirsk region "City Clinical Hospital # 2"
  • State autonomous institution of healthcare of the Perm Region" City clinical hospital #4"
  • FGBOU VO "The First St. Petersburg state medical university n. a. I.P. Pavlova"
  • OGBUZ "Smolensk Regional Clinical Hospital"
  • FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF
  • Scientific Research Institute of Antimicrobial Chemotherapy
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario Mutua de Terrassa
  • Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
  • Parc de Salut Mar- Hospital del Mar
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Reina Sofia
  • Hospital Universitario Ramon y Cajal
  • Hospital Regional Universitario de Malaga
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitari i Politecnic la Fe
  • Hospital Universitario Miguel Servet
  • National Taiwan University Hospital Yun-Lin Branch
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Veterans General Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Municipal Wanfang Hospital
  • Faculty of Medicine Siriraj Hospital
  • Srinagarind Hospital, Division of Infectious Disease and Tropical Medicine
  • Bamrasnaradura Infectious Disease Institute (BIDI)
  • Songklanagarind Hospital, Prince of Songkla University
  • Hacettepe Universitesi Tip Fakultesi
  • Ankara University Faculty of Medicine
  • T.C. Saglik Bakanligi Ankara Sehir Hastanesi
  • Acibadem Atakent Hospital
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
  • Ege University Faculty of Medicine
  • Kocaeli University Medical Faculty
  • Karadeniz Technical University Medical Faculty Farabi Hospital
  • OKU "Chernivetska oblasna klinichna likarnia", khirurhichne viddilennia
  • KZ "Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova", viddilennia khirurhii №2
  • Komunalnyi zaklad "Miska klinichna likarnia No.4" Dniprovskoi miskoi rady, viddilennia profpatolohii
  • Oblasna klinichna likarnia, viddilennia anesteziolohii ta intensyvnoi terapii
  • Ivano-Frankivska tsentralna miska klin likarnia, viddilennia khirurhii,
  • DU "Instytut zahalnoi ta nevidkladnoi khirurhii imeni V.T. Zaitseva Natsionalnoi akademii medychnykh
  • Kyivska miska klinichna likarnia No. 3, khirurhichne viddilennia
  • Kyivska miska klinichna likarnia #4, khirurhichne viddilennia #1
  • Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia
  • Odeska klinichna likarnia na zaliznychnomu transporti filii "Tsentr okhorony zdorovia" aktsionernoho
  • Komunalne pidpryiemstvo "1-a miska klinichna likarnia Poltavskoi miskoi rady",
  • Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aztreonam-Avibactam ± Metronidazole

Meropenem ± Colistin

Arm Description

All patients randomised to this arm will receive ATM-AVI; all patients with cIAI will receive MTZ for anaerobic cover

All patients randomised to this arm will receive MER; addition of COL will be at investigator's discretion in line with local practice

Outcomes

Primary Outcome Measures

Proportion of subjects with clinical cure in the ITT and CE analysis sets
Proportion of subjects meeting the criteria for clinical cure

Secondary Outcome Measures

Proportion of subjects with clinical cure in the m-ITT and ME analysis sets
Proportion of subjects meeting the criteria for clinical cure
Proportion of subjects with clinical cure by infection type in the ITT and CE analysis sets.
Proportion of subjects meeting the criteria for clinical cure
Proportion of subjects with clinical cure for subjects with MBL positive pathogens in the micro ITT and ME analysis sets.
Proportion of subjects meeting the criteria for clinical cure
Proportion of subjects with a favorable per subject microbiological response in the micro ITT and ME analysis sets.
Proportion of subjects with a favourable microbiological response (aggregate of eradication + presumed eradication)
Proportion of subjects who died
Daily mortality assessment
PK of ATM
Plasma concentration of ATM
PK/PD relationship between exposure and clinical response for ATM AVI±MTZ in the popPK analysis set
Correlation between plasma concentration of ATM and clinical cure
PK of AVI
Plasma concentration of AVI
PK/PD relationship between exposure and clinical response for ATM/AVI +/- MTZ in the popPK analysis set
Correlation between concentration of AVI and clinical cure
PK/PD relationship between exposure and microbiological response for ATM/AVI+/-MTZ in the popPK analysis set
Correlation between plasma concentration of ATM and microbiological response
PK/PD relationship between exposure and microbiological response for ATM/AVI+/-MTZ in the popPK analysis set
Correlation between plasma concentration of AVI and microbiological response
Description of safety in terms of adverse events
Descriptive summary of adverse events

Full Information

First Posted
October 6, 2017
Last Updated
June 23, 2023
Sponsor
Pfizer
Collaborators
Innovative Medicines Initiative (IMI) COMBACTE-CARE (EU), Biomedical Advanced Research and Development Authority
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1. Study Identification

Unique Protocol Identification Number
NCT03329092
Brief Title
A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
Acronym
REVISIT
Official Title
A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Innovative Medicines Initiative (IMI) COMBACTE-CARE (EU), Biomedical Advanced Research and Development Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram negative bacteria.
Detailed Description
A Phase 3 Prospective, Randomized, Multicenter, Open Label, Central Assessor Blinded, Parallel Group, Comparative Study To Determine The Efficacy, Safety And Tolerability Of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem±Colistin (MER±COL) For The Treatment Of Serious Infections Due To Gram Negative Bacteria, Including Metallo Β Lactamase (MBL) - Producing Multidrug Resistant Pathogens, For Which There Are Limited Or No Treatment Options

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia
Keywords
Complicated intra-abdominal infection, Hosptial acquired pneumonia, Ventilator associated pneumonia, Gram negative infections, Metallo-beta lactamase, Multi drug resistant pathogens

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized, Multicenter, Open Label, Central Assessor Blinded, Parallel Group, Comparative Study
Masking
Outcomes Assessor
Masking Description
An independent adjudication committee (central blinded assessor) will be convened at regular intervals during the study. The adjudication committee will be blinded to study treatment and will review the clinical response assessments at each visit. In case of a discrepancy with the Investigator's assignment of clinical response, the adjudication committee's assessment will prevail. In addition, for cIAI subjects classified as a clinical failure, and all cIAI subjects classified as a cure who undergo another procedure (eg, another surgical procedure) subsequent to randomization, the expert panel will review the adequacy of the surgical source control.
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aztreonam-Avibactam ± Metronidazole
Arm Type
Experimental
Arm Description
All patients randomised to this arm will receive ATM-AVI; all patients with cIAI will receive MTZ for anaerobic cover
Arm Title
Meropenem ± Colistin
Arm Type
Active Comparator
Arm Description
All patients randomised to this arm will receive MER; addition of COL will be at investigator's discretion in line with local practice
Intervention Type
Drug
Intervention Name(s)
ATM-AVI
Intervention Description
(Creatinine clearance > 50 mL/min) 6500 mg ATM/2167 mg (loading dose, extended loading dose and maintenance dose) by iv infusion on Day 1 followed by a total daily dose of 6000 mg ATM/2000 mg AVI (Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1417 mg AVI on Day 1 (loading dose, extended loading dose, maintenance dose) followed by total daily dose 3000 mg ATM/1000 mg AVI (Creatinine clearance 16 - 30 mL/min) 2700 mg ATM/900 mg AVI on Day 1 (loading dose, extended loading dose maintenance dose), followed by total daily dose 2025 mg ATM/675 mg AVI
Intervention Type
Drug
Intervention Name(s)
MTZ
Intervention Description
For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h
Intervention Type
Drug
Intervention Name(s)
MER
Intervention Description
Where pathogen initially not suspected of being MER-resistant: (Creatinine clearance > 50 mL/min) 1000 mg meropenem by 30 min iv infusion q8h (Creatinine clearance 26 - 50 mL/min) 1000mg meropenem by 30 min iv infusion q12h (Creatinine clearance 16 - 25 mL/min) 500 mg meropenem by 30 min iv infusion q12h Where pathogen initially suspected of being MER-resistant (Creatinine clearance > 50 mL/min) 2000 mg meropenem by 180 min iv infusion q8h (Creatinine clearance 26 - 50 mL/min) 2000 mg meropenem by 180 min iv infusion q12h (Creatinine clearance 16 - 25 mL/min) 1000 mg meropenem by 180 min iv infusion q12h
Intervention Type
Drug
Intervention Name(s)
COL
Intervention Description
Loading dose 9 million IU by 30 -60 min iv infusion (6 million IU where weight < 60 kg) followed by one of the following maintenance doses: (Creatinine clearance > 50 mL/min) after a 12h interval, commence maintenance dosing 9 million IU daily in 2 or 3 divided doses by 30 -60 min iv infusions. (Creatinine clearance 31 - 50 mL/min) After a 24 hr interval, commence maintenance dosing of 6 million IU daily in 2 divided doses by 30 -60 min iv infusion (Creatinine clearance 21 - 30 mL/min) After a 24 hr interval, commence maintenance dosing 5 million IU daily in 2 divided doses by 30 -60 min iv infusion (Creatinine clearance 16 - 20 mL/min) after a 24 hr interval, commence maintenance dosing 4 million IU daily in 2 divided doses by 30 -60 min iv infusion
Primary Outcome Measure Information:
Title
Proportion of subjects with clinical cure in the ITT and CE analysis sets
Description
Proportion of subjects meeting the criteria for clinical cure
Time Frame
Test of Cure (TOC) visit, Day 28 +/- 3 days
Secondary Outcome Measure Information:
Title
Proportion of subjects with clinical cure in the m-ITT and ME analysis sets
Description
Proportion of subjects meeting the criteria for clinical cure
Time Frame
Test of Cure (TOC) visit, Day 28 (+/- 3 days)
Title
Proportion of subjects with clinical cure by infection type in the ITT and CE analysis sets.
Description
Proportion of subjects meeting the criteria for clinical cure
Time Frame
Test of Cure (TOC) visit, Day 28 (+/- 3 days)
Title
Proportion of subjects with clinical cure for subjects with MBL positive pathogens in the micro ITT and ME analysis sets.
Description
Proportion of subjects meeting the criteria for clinical cure
Time Frame
Test of Cure (TOC) visit, Day 28 (+/- 3 days)
Title
Proportion of subjects with a favorable per subject microbiological response in the micro ITT and ME analysis sets.
Description
Proportion of subjects with a favourable microbiological response (aggregate of eradication + presumed eradication)
Time Frame
Test of Cure (TOC) visit, Day 28 (+/- 3 days)
Title
Proportion of subjects who died
Description
Daily mortality assessment
Time Frame
Day 28
Title
PK of ATM
Description
Plasma concentration of ATM
Time Frame
Days 1 and 4
Title
PK/PD relationship between exposure and clinical response for ATM AVI±MTZ in the popPK analysis set
Description
Correlation between plasma concentration of ATM and clinical cure
Time Frame
Test of Cure (TOC) visit, Day 28 (+/- 3 days)
Title
PK of AVI
Description
Plasma concentration of AVI
Time Frame
Days 1 and 4
Title
PK/PD relationship between exposure and clinical response for ATM/AVI +/- MTZ in the popPK analysis set
Description
Correlation between concentration of AVI and clinical cure
Time Frame
Test of Cure (TOC) days 28 (+/- 3 days)
Title
PK/PD relationship between exposure and microbiological response for ATM/AVI+/-MTZ in the popPK analysis set
Description
Correlation between plasma concentration of ATM and microbiological response
Time Frame
Test of Cure (TOC) visit, Days 28 (+/- 3 days)
Title
PK/PD relationship between exposure and microbiological response for ATM/AVI+/-MTZ in the popPK analysis set
Description
Correlation between plasma concentration of AVI and microbiological response
Time Frame
Test of Cure (TOC) visit, day 28 (+/- 3 days)
Title
Description of safety in terms of adverse events
Description
Descriptive summary of adverse events
Time Frame
Throughout study to Late Follow Up visit (Day 45 +/- 3 days)
Other Pre-specified Outcome Measures:
Title
Proportion of subjects with clinical cure in the ITT, micro ITT, CE and ME analysis sets
Description
Proportion of subjects meeting the criteria for clinical cure
Time Frame
End of Treatment (EOT) visit (variable, between Days 1 and 15)
Title
Proportion of subjects with clinical cure by infection type in the ITT and CE analysis sets
Description
Proportion of subjects meeting the criteria for clinical cure
Time Frame
End of Treatment (EOT) visit (variable, between Days 1 and 15)
Title
Proportion of subjects with a favorable per subject microbiological response in the the micro ITT and ME analysis sets
Description
Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)
Time Frame
End of Treatment (EOT) visit (variable, between Days 1 and 15)
Title
Proportion of subjects with a favorable per pathogen microbiological response in the micro ITT and ME analysis sets
Description
Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)
Time Frame
End of Treatment (EOT), (variable between Days 1 and 15)
Title
Proportion of subjects with a favorable per subject microbiological response by pathogen resistance type (eg, ATM resistant, ESBL positive, carbapenamase positive, MBL positive) in the micro ITT and ME analysis sets
Description
Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)
Time Frame
End of Treatment (EOT), (variable, between Days 1 and 15)
Title
Proportion of subjects with a favorable per pathogen microbiological response by pathogen resistance type in the micro ITT and ME analysis sets
Description
Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)
Time Frame
End of Treatment (EOT) visits, (variable between Days 1 and 15)
Title
Proportion of subjects with clinical cure using objective clinical measures
Description
Proportion of subjects with clinical cure
Time Frame
Test of Cure (TOC) visit, Day 28 +/- 3 days)
Title
Proportion of subjects who died
Description
Daily mortality assessment
Time Frame
Day 14
Title
Health resource utilization in terms of length of hospital stay
Description
Length of hospital stay (days), including any readmissions
Time Frame
Test of Cure (TOC), Day 28 +/- 3 days
Title
Relationship between (as yet undetermined) biomarkers and liver transaminase elevations in response to exposure to ATM-AVI
Description
Correlation between (yet to be determined) plasma biomarkers and elevated liver transaminases
Time Frame
Day 1 and 4
Title
Proportion of subjects with a favorable per pathogen microbiological response in the micro ITT and ME analysis sets
Description
Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)
Time Frame
Test of Cure (TOC) visit (Day 28 +/- 3 days)
Title
Proportion of subjects with a favorable per subject microbiological response by pathogen resistance type (eg, ATM resistant, ESBL positive, carbapenamase positive, MBL positive) in the micro ITT and ME analysis sets
Description
Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)
Time Frame
Test of Cure (TOC) visits, Day 28 +/- 3 days
Title
Proportion of subjects with a favorable per pathogen microbiological response by pathogen resistance type in the micro ITT and ME analysis sets
Description
Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)
Time Frame
Test of Cure (TOC) visits, Day 28 +/- 3 days
Title
Health resource utilization in terms of treatment duration
Description
Length of study treatment (days)
Time Frame
Test of Cure (TOC), Day 28 +/- 3 days
Title
Health resource utilization in terms of length of ICU stay
Description
Length of intensive care unit (ICU) stay (days)
Time Frame
Test of Cure (TOC), Day 28 +/- 3 days
Title
Health resource utilization in terms of transfer to ICU
Description
Transfer to the ICU (Yes/No)
Time Frame
Test of Cure (TOC), Day 28 +/- 3 days
Title
Health resource utilization in terms of use of mechanical ventilation
Description
Mechanical ventilation (Yes/No) for HAP/VAP subjects
Time Frame
Test of Cure (TOC), Day 28 +/- 3 days
Title
Health resource utilization in terms of duration of mechanical ventilation
Description
Length of mechanical ventilation (days) for HAP/VAP subjects
Time Frame
Test of Cure (TOC), Day 28 +/- 3 days
Title
Health resource utilization in terms of subsequent unplanned surgical intervention
Description
Subsequent unplanned surgical intervention (YES/NO) for cIAI subjects
Time Frame
Test of Cure (TOC), Day 28 +/- 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects: Male or female from 18 years of age Provision of informed consent Confirmed diagnosis of HAP/VAP or cIAI requiring iv antibiotic treatment Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met and negative pregnancy test Additional for cIAI: Diagnosis of cIAI, EITHER: Intra-operative/postoperative enrolment with visual confirmation of cIAI. OR Preoperative enrollment with evidence of systemic inflammatory response, physical and radiological findings consistent with cIAI; confirmation of cIAI at time of surgery within 24 hours of study entry Surgical intervention within 24 hours (before or after) the administration of the first dose of study drug Additional for HAP/VAP: Onset symptoms > 48h after admission to or <7 days after discharge from an inpatient care facility New or worsening infiltrate on CXR or CT scan Clinical signs and symptoms and laboratory findings consistent with HAP/VAP Respiratory specimen obtained for Gram stain and culture following onset of symptoms and prior to randomisation Exclusion criteria: All subjects: APACHE II score > 30 Confirmed or suspected infection caused by Gram-negative species not expected to respond to study drug, or Gram-positive species Receipt of >24 hr systemic antibiotic within 48h prior to randomisation (exception in case of treatment failure) History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other β-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs Known Clostridium difficle associated diarrhoea Requirement for effective concomitant systemic antibacterials or antifungals Creatinine clearance ≤15 ml/min or requirement or expectation for renal replacement therapy Acute hepatitis, cirrhosis, acute hepatic failure, chronic hepatic failure Hepatic disease as indicated by AST or ALT >3 × ULN. Patients with AST and/or ALT up to 5 × ULN are eligible if acute and documented by the investigator as being directly related infectious process Patient has a total bilirubin >2 × ULN, unless isolated hyperbilirubinemia is directly related to infectious process or due to known Gilbert's disease ALP >3 × ULN. Patients with values >3 × ULN and <5 x ULN are eligible if acute and directly related to the infectious process being treated Absolute neutrophil count <500/mm3 Pregnant or breastfeeding or if of child bearing potential, not using a medically accepted effective method of birth control. Any other condition that may confound the results of the study or pose additional risks to the subject Unlikely to comply with protocol History of epilepsy or seizure disorders excluding febrile seizures of childhood Additional for cIAI Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery < 24 hours of diagnosis primary etiology is not likely to be infectious Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess Prior liver, pancreas or small-bowel transplant Staged abdominal repair (STAR), open abdomen technique or marsupialisation Additional for HAP/VAP APACHE II score < 10 Known or high likelihood of Gram-positive monomicrobial infection Lung abscess, pleural empyema, post-obstructive pneumonia Lung or heart transplant Myasthenia gravis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Sanatorio Britanico
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Sanatorio Servicios Medicos SM
City
Santo Tome
State/Province
Santa FE
ZIP/Postal Code
S3016
Country
Argentina
Facility Name
Hospital San Roque
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
University Hospital Alexandrovska, Clinic of Anesthesiology and Intensive Care
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Hospital Queen Joanna ISUL, Clinic of Surgery
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment ''Prof.Dr Stoyan Kirkovich''AD
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Zhangzhou Municipal Hospital of Fujian Province
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
Facility Name
ZhuJiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Facility Name
The First Affiliated Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
The Second People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Nanning First People's Hospital
City
Nanning
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
530022
Country
China
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Facility Name
Changsha Third Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Hunan Province People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
014000
Country
China
Facility Name
Jiangyin People's Hospital
City
Jiangyin
State/Province
Jiangsu
ZIP/Postal Code
214400
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
The First people's Hospital of Kunming
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650034
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Taizhou Hospital of Zhejiang Province
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Facility Name
Lishui People's Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Name
Quzhou People's Hospital
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324000
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Jiangyin People's Hospital
City
Jiangyin
ZIP/Postal Code
214400
Country
China
Facility Name
Tianjin Union Medical Center
City
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Klinicka bolnica Merkur
City
Zagreb
State/Province
GRAD Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Rijeka
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Facility Name
University Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
General Hospital "Dr. Josip Bencevic" Slavonski Brod
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Facility Name
Clinical Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Nemocnice Decin, o.z.
City
Decin
ZIP/Postal Code
40599
Country
Czechia
Facility Name
Lekarna Nemocnice Decin, Krajska zdravotni, a.s.- Nemocnice Decin, o.z.
City
Decin
ZIP/Postal Code
40599
Country
Czechia
Facility Name
Public Hospital Kolin, a.s.
City
Kolin III
ZIP/Postal Code
280 02
Country
Czechia
Facility Name
Nemocnice Kyjov, prispevkova organizace
City
Kyjov
ZIP/Postal Code
697 01
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
General Hospital of Athens "Evangelismos"
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
General and Chest Diseases Hospital "Sotiria"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital "ATTIKON"
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion, Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Koutlimbaneio and Triantafylleio General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41221
Country
Greece
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Victoria Hospital, Bangalore Medical College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
M S Ramaiah Medical College and Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Kasturba Medical College and Hospital
City
Manipal
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Facility Name
JSS Hospital
City
Mysuru
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Amrita Institute of Medical Sciences & Research Centre
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Government Medical College, Kozhikode
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673008
Country
India
Facility Name
Deenanath Mangeshkar Hospital And Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Sahyadri Super Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Sahyadri Super Specialty Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
S.R. Kalla Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
Apollo Hospitals
City
Chennai
State/Province
Tamil NADU
ZIP/Postal Code
600006
Country
India
Facility Name
King George's Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Sahyadri Clinical Research & Development Center
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Sahyadri Specialty Hospital
City
Pune
Country
India
Facility Name
Assuta Ashdod University Hospital
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Shamir Medical Center, Infectious Diseases Unit
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Ospedali Riuniti
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Farmacia Ospedaliera - Direzione Assistenza Farmaceutica
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
SC di Radiologia - Azienda Ospedaliera Universitaria di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
UO Radiognastostica 2 Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
UO Farmaceutica Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Gachon University Gil Medical Center - Infectious Disease
City
Incheon
State/Province
Incheon Gwang'yeogsiv
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Hospital Seberang Jaya
City
Seberang Jaya
State/Province
Pulau Pinang
ZIP/Postal Code
13700
Country
Malaysia
Facility Name
Hospital Sultanah Nur Zahirah
City
Kuala Terengganu
State/Province
Terengganu
ZIP/Postal Code
20400
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
De La Salle Medical and Health Sciences Institute
City
City Of Dasmarinas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Baguio General Hospital and Medical Center
City
Baguio City
ZIP/Postal Code
2600
Country
Philippines
Facility Name
Davao Doctors Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
St. Paul's Hospital of Iloilo, Inc.
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
West Visayas State University Medical Center
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Philippine General Hospital, Central Intensive Care Unit
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Asian Hospital and Medical Center
City
Muntinlupa City
ZIP/Postal Code
1780
Country
Philippines
Facility Name
Quirino Memorial Medical Center
City
Quezon City
ZIP/Postal Code
1109
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1112
Country
Philippines
Facility Name
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
City
Bucuresti
ZIP/Postal Code
021105
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase si tropicale "Dr. Victor Babes"
City
Bucuresti
ZIP/Postal Code
030303
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400348
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase "Sf. Parascheva" Iasi
City
Iasi
ZIP/Postal Code
700116
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
City
Timisoara
ZIP/Postal Code
300723
Country
Romania
Facility Name
Private Healthcare Institution "Clinical Hospital 'Russian Railroad Medicine, Chelyabinsk'"
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Regional Clinical Hospital No. 2" of the Ministry of Health
City
Krasnodar
ZIP/Postal Code
350012
Country
Russian Federation
Facility Name
GBUZ of Novosibirsk region "City Clinical Hospital # 2"
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
State autonomous institution of healthcare of the Perm Region" City clinical hospital #4"
City
Perm
ZIP/Postal Code
614107
Country
Russian Federation
Facility Name
FGBOU VO "The First St. Petersburg state medical university n. a. I.P. Pavlova"
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
OGBUZ "Smolensk Regional Clinical Hospital"
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Scientific Research Institute of Antimicrobial Chemotherapy
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Parc de Salut Mar- Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic la Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
National Taiwan University Hospital Yun-Lin Branch
City
Douliou
State/Province
Yunlin
ZIP/Postal Code
64041
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Municipal Wanfang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Srinagarind Hospital, Division of Infectious Disease and Tropical Medicine
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Infectious Disease Institute (BIDI)
City
Muang
State/Province
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Songklanagarind Hospital, Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
T.C. Saglik Bakanligi Ankara Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Acibadem Atakent Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Ege University Faculty of Medicine
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Karadeniz Technical University Medical Faculty Farabi Hospital
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
OKU "Chernivetska oblasna klinichna likarnia", khirurhichne viddilennia
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
KZ "Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova", viddilennia khirurhii №2
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Komunalnyi zaklad "Miska klinichna likarnia No.4" Dniprovskoi miskoi rady, viddilennia profpatolohii
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Oblasna klinichna likarnia, viddilennia anesteziolohii ta intensyvnoi terapii
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Ivano-Frankivska tsentralna miska klin likarnia, viddilennia khirurhii,
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
DU "Instytut zahalnoi ta nevidkladnoi khirurhii imeni V.T. Zaitseva Natsionalnoi akademii medychnykh
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Kyivska miska klinichna likarnia No. 3, khirurhichne viddilennia
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Kyivska miska klinichna likarnia #4, khirurhichne viddilennia #1
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Odeska klinichna likarnia na zaliznychnomu transporti filii "Tsentr okhorony zdorovia" aktsionernoho
City
Odesa
ZIP/Postal Code
65059
Country
Ukraine
Facility Name
Komunalne pidpryiemstvo "1-a miska klinichna likarnia Poltavskoi miskoi rady",
City
Poltava
ZIP/Postal Code
36039
Country
Ukraine
Facility Name
Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3601002
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.

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