search
Back to results

Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)

Primary Purpose

Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IMI/REL FDC
PIP/TAZ FDC
Linezolid
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hospital-Acquired Bacterial Pneumonia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Requires treatment with IV antibiotic therapy for HABP or VABP
  • Fulfills clinical and radiographic criteria within 48 hours prior to randomization, with onset of criteria occurring after more than 2 days of hospitalization or within 7 days after discharge from a hospital for HABP; or at least 2 days after mechanical ventilation (for VABP)
  • Has an adequate baseline (at or within 2 days of screening) lower respiratory tract specimen obtained for Gram stain and culture
  • Has an infection known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the IV study therapy
  • Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing and long-term storage
  • Males agree to use contraception as detailed in protocol from the time of providing informed consent through completion of the study and refrain from donating sperm during this period
  • Females are not pregnant, not breastfeeding, and are either: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance from the time of providing informed consent through completion of the study
  • If a penicillin skin test is required by local clinical practice, the participant must have a negative skin test result for allergy to penicillin

Exclusion Criteria:

  • Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only
  • Has confirmed or suspected community-acquired bacterial pneumonia (CABP)
  • Has confirmed or suspected pneumonia caused by Mycoplasma, Chlamydia, or Legionella, or of viral, fungal, or parasitic etiology
  • Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction
  • Has a carcinoid tumor or carcinoid syndrome
  • Has active immunosuppression
  • Is expected to die during the 7- to 14-day treatment period, despite adequate antibiotic therapy
  • Has a concurrent condition or infection that, in the investigator's judgment, would preclude evaluation of therapeutic response
  • Has a history of serious allergy, hypersensitivity, or any serious reaction to any β-lactams or β-lactamase inhibitors
  • Has a history of a seizure disorder which has required ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years
  • Is currently undergoing hemodialysis or peritoneal dialysis
  • A WOCBP who has a positive urine pregnancy test at screening
  • Has received effective antibacterial drug therapy with known coverage of pathogens that cause HABP/VABP for a continuous duration of more than 48 hours during the previous 72 hours
  • Is anticipated to be treated with any of the prohibited medications during the course of study therapy
  • Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 90 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial
  • Has previously participated in this study at any time

Sites / Locations

  • Santa Casa de Misericordia de Belo Horizonte ( Site 0300)
  • Hospital de Base de Sao Jose de Rio Preto ( Site 0301)
  • Beijing Chaoyang Hospital ( Site 0126)
  • Peking University First Hospital ( Site 0131)
  • Aero Space center hospital ( Site 0118)
  • The Seventh Medical Center of PLA General Hospital-Intensive medicine ( Site 0157)
  • Peking University Third Hospital ( Site 0115)
  • Beijing Hospital ( Site 0127)
  • The First Affiliated Hospital Of Fujian Medical University-Respiratory ( Site 0136)
  • Zhongshan Hospital Affiliated to Xiamen University ( Site 0133)
  • Zhangzhou Municipal Hospital of Fujian Province-Neurosurgery Department ( Site 0150)
  • The First Affiliated Hospital ( Site 0100)
  • The First Affiliated Hospital of Guangzhou Medical University ( Site 0123)
  • Guangzhou First People's Hospital ( Site 0101)
  • Zhujiang Hospital of Southern Medical University ( Site 0148)
  • Southern Medical University Nanfang Hospital ( Site 0120)
  • Huizhou Municipal Central Hospital ( Site 0140)
  • Shenzhen People s Hospital ( Site 0134)
  • The first people s hospital of Nanning ( Site 0138)
  • The first people s hospital of Nanning ( Site 0141)
  • Hainan General Hospital ( Site 0106)
  • The First Affiliated Hospital of Zhengzhou University ( Site 0121)
  • Shiyan City People's Hospital-Neurosurgery ( Site 0155)
  • Changsha Central Hospital ( Site 0119)
  • Hunan Provincial People Hospital ( Site 0122)
  • The First People's Hospital of Changzhou ( Site 0139)
  • First Huai'an Hospital Affiliated to Nanjing Medical University-Neurosurgery Department ( Site 0153)
  • First Hospital Affiliated to Suzhou University ( Site 0111)
  • Wuxi People's Hospital ( Site 0124)
  • Affiliated Hospital of Jiangsu University ( Site 0147)
  • Jiangxi Provincial People's Hospital ( Site 0129)
  • The First Affiliated Hospital of Nanchang University ( Site 0132)
  • The Second Affiliated Hospital of Nanchang University-Neurosurgery Department ( Site 0151)
  • The First Affiliated Hospital of China Medical University ( Site 0116)
  • General Hospital of Ningxia Medical University ( Site 0135)
  • People's Hospital of Liaocheng City-Neurology ( Site 0154)
  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine ( Site 0104)
  • Huadong Hospital Affiliated Fudan University ( Site 0103)
  • Huashan Hospital of Fudan University ( Site 0105)
  • Shanghai General Hospital ( Site 0125)
  • Shanghai Pulmonary Hospital ( Site 0108)
  • Tianjin Medical University General Hospital ( Site 0113)
  • The First Affiliated Hospital.Zhejiang University ( Site 0102)
  • Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 0110)
  • People s Hospital of Lishui City ( Site 0137)
  • Ningbo First Hospital-neurosurgery ( Site 0152)
  • The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0130)
  • Hopital Roger Salengro du Lille ( Site 0601)
  • CHU de Nantes - Hotel Dieu ( Site 0600)
  • Hospices Civils de Lyon ( Site 0603)
  • Hopital Bicetre ( Site 0605)
  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
  • Hospital Civil Nuevo de Guadalajara Dr. Juan I. Menchaca ( Site 0804)
  • Mary Johnston Hospital ( Site 0901)
  • Lung Center of the Philippines ( Site 0903)
  • West Visayas State University Medical Center ( Site 0900)
  • Spitalul Clinic Judetean de Urgenta Pius Branzeu ( Site 1103)
  • Spitalul Clinic de Urgenta Bagdasar-Arseni ( Site 1101)
  • First City Clinical Hospital n.a. E.E.Volosevich ( Site 1016)
  • City Hospital #2 Severodvinsk ( Site 1017)
  • Research Institute of Emergency Medicine n.a. I.I.Dzhanelidze ( Site 1011)
  • Clinical Hospital #122 L.G. Sokolova FMBA ( Site 1015)
  • City Hospital #26 ( Site 1002)
  • ME Dnipropetrovsk Clinical Joinder of Emergency Care of DRC ( Site 1304)
  • Ivano-Frankivsk regional clinical hospital ( Site 1301)
  • City Clinical Hospital No13 of Kharkiv City Council ( Site 1303)
  • Kiyv city municipal hospital 17 ( Site 1300)
  • Reg. Clin. Hospital ( Site 1306)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMI/REL FDC

PIP/TAZ FDC

Arm Description

Imipenem/cilastatin/relebactam (IMI/REL) administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Piperacillin/tazobactam (PIP/TAZ ) administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.

Outcomes

Primary Outcome Measures

Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population
For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented.

Secondary Outcome Measures

Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population
Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented.
Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population
Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented.
Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population
Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy was required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented.
Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population
Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy is required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented.
Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population
Favorable overall microbiological response rates were defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented.
Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population.
A favorable by-pathogen microbiological response at EFU visit required "eradication" (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented.
Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population
Favorable overall microbiological response rates was defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented.
Percentage of Participants Experiencing Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm.
Percentage of Participants Discontinuing Study Drug Due to AEs
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm.

Full Information

First Posted
June 28, 2018
Last Updated
June 27, 2023
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03583333
Brief Title
Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)
Official Title
A Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) [IMI/REL, MK-7655A] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMI/REL FDC
Arm Type
Experimental
Arm Description
Imipenem/cilastatin/relebactam (IMI/REL) administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
Arm Title
PIP/TAZ FDC
Arm Type
Active Comparator
Arm Description
Piperacillin/tazobactam (PIP/TAZ ) administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.
Intervention Type
Drug
Intervention Name(s)
IMI/REL FDC
Other Intervention Name(s)
MK-7655A
Intervention Description
500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial
Intervention Type
Drug
Intervention Name(s)
PIP/TAZ FDC
Intervention Description
4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial
Intervention Type
Drug
Intervention Name(s)
Linezolid
Intervention Description
Open-label 600 mg Linezolid
Primary Outcome Measure Information:
Title
Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population
Description
For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented.
Time Frame
Up to approximately 28 days
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population
Description
Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented.
Time Frame
Up to approximately 27 days
Title
Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population
Description
Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented.
Time Frame
Up to approximately 27 days
Title
Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population
Description
Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy was required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented.
Time Frame
Up to approximately 14 days
Title
Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population
Description
Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy is required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented.
Time Frame
Up to approximately 14 days
Title
Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population
Description
Favorable overall microbiological response rates were defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented.
Time Frame
Up to approximately 14 days
Title
Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population.
Description
A favorable by-pathogen microbiological response at EFU visit required "eradication" (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented.
Time Frame
Up to approximately 27 days
Title
Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population
Description
Favorable overall microbiological response rates was defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented.
Time Frame
Up to approximately 14 days
Title
Percentage of Participants Experiencing Adverse Events (AEs)
Description
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm.
Time Frame
Up to approximately 98 days
Title
Percentage of Participants Discontinuing Study Drug Due to AEs
Description
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm.
Time Frame
Up to approximately 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Requires treatment with IV antibiotic therapy for HABP or VABP Fulfills clinical and radiographic criteria within 48 hours prior to randomization, with onset of criteria occurring after more than 2 days of hospitalization or within 7 days after discharge from a hospital for HABP; or at least 2 days after mechanical ventilation (for VABP) Has an adequate baseline (at or within 2 days of screening) lower respiratory tract specimen obtained for Gram stain and culture Has an infection known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the IV study therapy Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing and long-term storage Males agree to use contraception as detailed in protocol from the time of providing informed consent through completion of the study and refrain from donating sperm during this period Females are not pregnant, not breastfeeding, and are either: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance from the time of providing informed consent through completion of the study If a penicillin skin test is required by local clinical practice, the participant must have a negative skin test result for allergy to penicillin Exclusion Criteria: Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only Has confirmed or suspected community-acquired bacterial pneumonia (CABP) Has confirmed or suspected pneumonia caused by Mycoplasma, Chlamydia, or Legionella, or of viral, fungal, or parasitic etiology Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction Has a carcinoid tumor or carcinoid syndrome Has active immunosuppression Is expected to die during the 7- to 14-day treatment period, despite adequate antibiotic therapy Has a concurrent condition or infection that, in the investigator's judgment, would preclude evaluation of therapeutic response Has a history of serious allergy, hypersensitivity, or any serious reaction to any β-lactams or β-lactamase inhibitors Has a history of a seizure disorder which has required ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years Is currently undergoing hemodialysis or peritoneal dialysis A WOCBP who has a positive urine pregnancy test at screening Has received effective antibacterial drug therapy with known coverage of pathogens that cause HABP/VABP for a continuous duration of more than 48 hours during the previous 72 hours Is anticipated to be treated with any of the prohibited medications during the course of study therapy Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 90 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial Has previously participated in this study at any time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Santa Casa de Misericordia de Belo Horizonte ( Site 0300)
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital de Base de Sao Jose de Rio Preto ( Site 0301)
City
Sao Jose Do Rio Preto - SP
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Beijing Chaoyang Hospital ( Site 0126)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Peking University First Hospital ( Site 0131)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Aero Space center hospital ( Site 0118)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100049
Country
China
Facility Name
The Seventh Medical Center of PLA General Hospital-Intensive medicine ( Site 0157)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100073
Country
China
Facility Name
Peking University Third Hospital ( Site 0115)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Beijing Hospital ( Site 0127)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Affiliated Hospital Of Fujian Medical University-Respiratory ( Site 0136)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Zhongshan Hospital Affiliated to Xiamen University ( Site 0133)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Zhangzhou Municipal Hospital of Fujian Province-Neurosurgery Department ( Site 0150)
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
Facility Name
The First Affiliated Hospital ( Site 0100)
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University ( Site 0123)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Guangzhou First People's Hospital ( Site 0101)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Zhujiang Hospital of Southern Medical University ( Site 0148)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Facility Name
Southern Medical University Nanfang Hospital ( Site 0120)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Huizhou Municipal Central Hospital ( Site 0140)
City
Huizhou
State/Province
Guangdong
Country
China
Facility Name
Shenzhen People s Hospital ( Site 0134)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
The first people s hospital of Nanning ( Site 0138)
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530022
Country
China
Facility Name
The first people s hospital of Nanning ( Site 0141)
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530022
Country
China
Facility Name
Hainan General Hospital ( Site 0106)
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University ( Site 0121)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Shiyan City People's Hospital-Neurosurgery ( Site 0155)
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Facility Name
Changsha Central Hospital ( Site 0119)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410004
Country
China
Facility Name
Hunan Provincial People Hospital ( Site 0122)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
The First People's Hospital of Changzhou ( Site 0139)
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
First Huai'an Hospital Affiliated to Nanjing Medical University-Neurosurgery Department ( Site 0153)
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
First Hospital Affiliated to Suzhou University ( Site 0111)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215008
Country
China
Facility Name
Wuxi People's Hospital ( Site 0124)
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Affiliated Hospital of Jiangsu University ( Site 0147)
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Facility Name
Jiangxi Provincial People's Hospital ( Site 0129)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University ( Site 0132)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University-Neurosurgery Department ( Site 0151)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Affiliated Hospital of China Medical University ( Site 0116)
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
General Hospital of Ningxia Medical University ( Site 0135)
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
People's Hospital of Liaocheng City-Neurology ( Site 0154)
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
Ruijin Hospital Shanghai Jiao Tong University School of Medicine ( Site 0104)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Huadong Hospital Affiliated Fudan University ( Site 0103)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Huashan Hospital of Fudan University ( Site 0105)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai General Hospital ( Site 0125)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Shanghai Pulmonary Hospital ( Site 0108)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Facility Name
Tianjin Medical University General Hospital ( Site 0113)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
The First Affiliated Hospital.Zhejiang University ( Site 0102)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 0110)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
People s Hospital of Lishui City ( Site 0137)
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Name
Ningbo First Hospital-neurosurgery ( Site 0152)
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0130)
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Hopital Roger Salengro du Lille ( Site 0601)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Nantes - Hotel Dieu ( Site 0600)
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44093
Country
France
Facility Name
Hospices Civils de Lyon ( Site 0603)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Bicetre ( Site 0605)
City
Le Kremlin-Bicetre
State/Province
Val-de-Marne
ZIP/Postal Code
94270
Country
France
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Civil Nuevo de Guadalajara Dr. Juan I. Menchaca ( Site 0804)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Mary Johnston Hospital ( Site 0901)
City
Metro Manila
State/Province
National Capital Region
ZIP/Postal Code
1012
Country
Philippines
Facility Name
Lung Center of the Philippines ( Site 0903)
City
Quezon
State/Province
National Capital Region
ZIP/Postal Code
1104
Country
Philippines
Facility Name
West Visayas State University Medical Center ( Site 0900)
City
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Spitalul Clinic Judetean de Urgenta Pius Branzeu ( Site 1103)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300723
Country
Romania
Facility Name
Spitalul Clinic de Urgenta Bagdasar-Arseni ( Site 1101)
City
Bucuresti
ZIP/Postal Code
041915
Country
Romania
Facility Name
First City Clinical Hospital n.a. E.E.Volosevich ( Site 1016)
City
Arkhangelsk
State/Province
Arkhangel Skaya Oblast
ZIP/Postal Code
163001
Country
Russian Federation
Facility Name
City Hospital #2 Severodvinsk ( Site 1017)
City
Severodvinsk
State/Province
Arkhangel Skaya Oblast
ZIP/Postal Code
164500
Country
Russian Federation
Facility Name
Research Institute of Emergency Medicine n.a. I.I.Dzhanelidze ( Site 1011)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Clinical Hospital #122 L.G. Sokolova FMBA ( Site 1015)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
City Hospital #26 ( Site 1002)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
ME Dnipropetrovsk Clinical Joinder of Emergency Care of DRC ( Site 1304)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49006
Country
Ukraine
Facility Name
Ivano-Frankivsk regional clinical hospital ( Site 1301)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
City Clinical Hospital No13 of Kharkiv City Council ( Site 1303)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Kiyv city municipal hospital 17 ( Site 1300)
City
Kiev
State/Province
Kyivska Oblast
ZIP/Postal Code
01133
Country
Ukraine
Facility Name
Reg. Clin. Hospital ( Site 1306)
City
Poltava
State/Province
Poltavska Oblast
ZIP/Postal Code
36000
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)

We'll reach out to this number within 24 hrs