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Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections

Primary Purpose

cUTI

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eravacycline
Levofloxacin
Sponsored by
Tetraphase Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for cUTI

Eligibility Criteria

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

Inclusion Criteria:

1. Male and female participants with either:

a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR b. cUTI with at least 1 of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately 100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not congestive heart failure or volume related) such that the serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN: creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as, bladder diverticula, redundant urine collection system) EXCEPT surgery within the last month

Exclusion Criteria:

1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in participants with cUTI, including:

  1. Participants with a history of a levofloxacin-resistant urinary tract infection
  2. Likely to receive ongoing antibacterial drug prophylaxis prior to the late Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)

Sites / Locations

  • San Diego Clinical Trials
  • Harbor-UCLA Medical Center
  • Tampa General Hospital
  • Henry Ford Hospital
  • Sunrise Hospital and Medical Centre
  • Columbus Regional Research Institute
  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Nephrology
  • Multiprofile Hospital for Active Treatment "Dr. Stamen Iliev", Montana, Department of Nephrology and Dialysis
  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
  • Multiprofile Hospital for Active Treatment, Ruse, Department of Urology
  • Multiprofile Hospital for Active Treatment, Sofia at Military Medical Academy, General Urology Clinic
  • University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Department of Laparoscopic Urology
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
  • Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology
  • Fundacion Cardiomet
  • De la Costa Clinic. Ltd. Research Centre
  • University Hospital Brno, Clinic of Urology
  • University Hospital Hradec Kralove, Clinic of Urology
  • Hospital Novy Jicin, Department of Urology
  • University Hospital Olomouc
  • Thomayer Hospital, Department of Urology
  • East Viru Central Hospital, Surgery Clinic
  • East Tallinn Central Hospital, Department of Internal Medicine
  • West Tallinn Central Hospital, Department of Urology
  • Tartu University Hospital, Surgery Clinic, Department of Urology and Renal Transplantation
  • Western Georgia National Medical Center
  • Aversi Clinic
  • Modern Medical Technologies - Guram Karazanashvili's clinic
  • Research Institute of Clinical Medicine
  • Tsulukidze National Center of Urology
  • Evaggelismos Hospital
  • Papageorgiou General Hospital
  • Principal SMO Kft.
  • Jahn Ferenc South Pest Hospital, Department of Urology
  • Petz Aladar County Teaching Hospital, Department of Urology
  • Elisabeth Teaching Hospital and Rehabilitation Institute of Sopron, Department of Urology
  • Csongrad County Dr. Bugyi Istvan Hospital, Department of Urology
  • St. Borbala Hospital, Department of Urology
  • Zion Medical Center
  • Hospital Mater Domini
  • Liepajas Regional Hospital
  • P. Stradins Clinical University Hospital
  • Riga East University Hospital, LLC
  • SIA 'URO' Clinic
  • Vidzemes Hospital
  • Hospital Civil Fray Antonio Alcalde
  • Hospital Civil Guadalajara Dr. Juan I. Mendoza
  • National Scientific Practical Center for Emergency Medicine, Department of Urology
  • Republican Clinical Hospital, Department of Urology
  • Boni Fratres Catoviensis Sp. z o.o., Department of Internal Diseases with Cardiologic Diagnostics Unit
  • Military Medical Academy University Teaching Hospital - Central Veterans' Hospital, Clinical and Didactic Center of the Medical University of Lodz, Teaching Department of Nephrology, Hypertension and Renal Transplantation
  • Medicome Sp. z o.o.
  • HEUREKA Hanna Szalecka
  • Pope John Paul 2nd Independent Public Provincial Hospital
  • Emergency Clinical County Hospital Brasov
  • "Prof. Dr. Th. Burghele" Clinical Hospital
  • Delta Hospital
  • Craiova Emergency Clinical County Hospital
  • Clinical Hospital "Dr. C. I. Parhon"
  • Oradea Clinical Municipal Hospital "Dr. Gavril Curteanu"
  • Sibiu County Emergency Clinical Hospital
  • Central Clinical Hospital of Civil Aviation
  • City Clinical Hospital #57 under Moscow Healthcare Department
  • Federal Clinical Center for High Medical Technologies
  • City Clinical Hospital of Emergency Care #2
  • Penza Regional Clinical Hospital n.a. N.N. Burdenko
  • Rostov State Medical University
  • North-Western State Medical University n.a. I.I. Mechnikov
  • Saint-Petersburg Scientific Research Institute for Phthisiopulmonology
  • St. Petersburg Clinical Hospital under the Russian Academy of Sciences
  • St. Petersburg State Healthcare Institution: City Hospital #15
  • St. Petersburg State Healthcare Institution: St. George the Martyr City Hospital
  • St. Petersburg State-Funded Healthcare Institution: City Hospital #26
  • Saratov State Medical University n.a. V.I. Razumovsky
  • Smolensk Regional Clinical Hospital
  • Novgorod Regional Clinical Hospital
  • Vsevolozhsk Clinical Central District Hospital
  • Lakeview Hospital
  • Clinresco Centres
  • Mzansi Ethical Research Centre
  • St. Georges Hospital
  • Regional Municipal Institution "Chernivtsi Regional Hospital"
  • Dnipropetrovsk City Multispecialty Clinical Hospital #4
  • Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital
  • Ivano-Frankivsk City Clinical Hospital #1
  • Ivano-Frankivsk Regional Clinical Hospital
  • O.I. Meschaninov Clinical Hospital of Emergency and Urgent Medical Care
  • Shapoval Regional Clinical Center of Urology and Nephrology
  • Khmelnytskyi Regional Hospital
  • Institute of Urology
  • Lviv Regional Clinical Hospital
  • Volyn Regional Clinical Hospital
  • Mykolaiv Regional Hospital, Center for Nephrology and Dialysis
  • City Clinical Hospital #10, Urology Department #1
  • Odesa Regional Clinical Hospital
  • Poltava M.V. Sklifosovskyi Regional Clinical Hospital
  • State Institution: Uzhhorod Railway Station Clinical Hospital under State Territorial Industry-Specific Association:Lviv Railway
  • Vinnytsia M.I. Pyrohov Regional Clinical Hospital
  • Municipal Institution "Zaporizhzhia Reqional Clinical Hospital" of Zaporizhzhia Regional Councill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eravacycline

Levofloxacin

Arm Description

Eravacycline was administered IV at a dose of 1.5 mg per kilogram (kg) of body weight every 24 hours (q24h). At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO twice a day for a total therapy of 7 dosing cycles.

Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day for a total therapy of 7 dosing cycles.

Outcomes

Primary Outcome Measures

Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit
This was the primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to levofloxacin in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to <10^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.

Secondary Outcome Measures

Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response
This outcome measure (FDA and the European Medicines Agency [EMA]) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the micro-MITT population. Responses were success, failure, or indeterminate/missing. Success was considered a reduction of the baseline pathogen(s) to <10^4 CFU/mL. Failure required blood cultures at or beyond end of therapy (EOT) to be positive for baseline pathogen(s), or urine culture to grow ≥10^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available.
Participants In The Microbiologically Evaluable (ME) Population With A Microbiological Response
This outcome measure (FDA and EMA) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the ME population. Responses were either success or failure. Indeterminate/missing responses were not included. Success was considered a reduction of the baseline pathogen(s) to <10^4 CFU/mL. Failure required blood cultures at or beyond EOT to be positive for baseline pathogen(s), or urine culture to grow ≥10^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available. Populations: ME, all micro-ITT and clinically-evaluable (CE) participants with a suitable urine specimen and an interpretable urine culture; micro-ITT, all participants with ≥1 baseline bacterial pathogen from a urine or blood culture that caused a UTI against which eravacycline had expected antibacterial activity; ITT, all randomized participants, regardless of receiving study drug or not.

Full Information

First Posted
October 28, 2013
Last Updated
December 21, 2021
Sponsor
Tetraphase Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01978938
Brief Title
Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
Official Title
A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2014 (Actual)
Primary Completion Date
June 3, 2015 (Actual)
Study Completion Date
August 21, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tetraphase Pharmaceuticals, Inc.

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
This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).
Detailed Description
This study began with a 3-arm Lead-in portion to determine the oral (PO) dosing (200 or 250 milligrams [mg]) of eravacycline to be used with intravenously (IV) administered eravacycline for the Pivotal portion (2 arms). A PO dose of 200 mg was selected based on the unblinded Lead-in analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
cUTI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Except for the responsible study site pharmacist or designee and separate unblinded clinical research associates to monitor drug supply and adherence to study drug blinding and randomization procedures, all study staff and participants were blinded to treatment assignment.
Allocation
Randomized
Enrollment
908 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eravacycline
Arm Type
Experimental
Arm Description
Eravacycline was administered IV at a dose of 1.5 mg per kilogram (kg) of body weight every 24 hours (q24h). At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO twice a day for a total therapy of 7 dosing cycles.
Arm Title
Levofloxacin
Arm Type
Active Comparator
Arm Description
Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day for a total therapy of 7 dosing cycles.
Intervention Type
Drug
Intervention Name(s)
Eravacycline
Other Intervention Name(s)
TP-434
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Levaquin
Primary Outcome Measure Information:
Title
Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit
Description
This was the primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to levofloxacin in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to <10^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.
Time Frame
PT Visit
Secondary Outcome Measure Information:
Title
Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response
Description
This outcome measure (FDA and the European Medicines Agency [EMA]) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the micro-MITT population. Responses were success, failure, or indeterminate/missing. Success was considered a reduction of the baseline pathogen(s) to <10^4 CFU/mL. Failure required blood cultures at or beyond end of therapy (EOT) to be positive for baseline pathogen(s), or urine culture to grow ≥10^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available.
Time Frame
PT Visit
Title
Participants In The Microbiologically Evaluable (ME) Population With A Microbiological Response
Description
This outcome measure (FDA and EMA) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the ME population. Responses were either success or failure. Indeterminate/missing responses were not included. Success was considered a reduction of the baseline pathogen(s) to <10^4 CFU/mL. Failure required blood cultures at or beyond EOT to be positive for baseline pathogen(s), or urine culture to grow ≥10^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available. Populations: ME, all micro-ITT and clinically-evaluable (CE) participants with a suitable urine specimen and an interpretable urine culture; micro-ITT, all participants with ≥1 baseline bacterial pathogen from a urine or blood culture that caused a UTI against which eravacycline had expected antibacterial activity; ITT, all randomized participants, regardless of receiving study drug or not.
Time Frame
PT Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Male and female participants with either: a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR b. cUTI with at least 1 of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately 100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not congestive heart failure or volume related) such that the serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN: creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as, bladder diverticula, redundant urine collection system) EXCEPT surgery within the last month Exclusion Criteria: 1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in participants with cUTI, including: Participants with a history of a levofloxacin-resistant urinary tract infection Likely to receive ongoing antibacterial drug prophylaxis prior to the late Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)
Facility Information:
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Sunrise Hospital and Medical Centre
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Nephrology
City
Gabrovo
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Dr. Stamen Iliev", Montana, Department of Nephrology and Dialysis
City
Montana
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
City
Pleven
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment, Ruse, Department of Urology
City
Rousse
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment, Sofia at Military Medical Academy, General Urology Clinic
City
Sofia
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Department of Laparoscopic Urology
City
Sofia
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
City
Sofia
Country
Bulgaria
Facility Name
Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Fundacion Cardiomet
City
Armenia
Country
Colombia
Facility Name
De la Costa Clinic. Ltd. Research Centre
City
Barranquilla
Country
Colombia
Facility Name
University Hospital Brno, Clinic of Urology
City
Brno
Country
Czechia
Facility Name
University Hospital Hradec Kralove, Clinic of Urology
City
Hradec Kralove
Country
Czechia
Facility Name
Hospital Novy Jicin, Department of Urology
City
Novy Jicin
Country
Czechia
Facility Name
University Hospital Olomouc
City
Olomouc
Country
Czechia
Facility Name
Thomayer Hospital, Department of Urology
City
Prague
Country
Czechia
Facility Name
East Viru Central Hospital, Surgery Clinic
City
Kohtla-Jarve
Country
Estonia
Facility Name
East Tallinn Central Hospital, Department of Internal Medicine
City
Tallinn
Country
Estonia
Facility Name
West Tallinn Central Hospital, Department of Urology
City
Tallinn
Country
Estonia
Facility Name
Tartu University Hospital, Surgery Clinic, Department of Urology and Renal Transplantation
City
Tartu
Country
Estonia
Facility Name
Western Georgia National Medical Center
City
Kutaisi
Country
Georgia
Facility Name
Aversi Clinic
City
Tbilisi
Country
Georgia
Facility Name
Modern Medical Technologies - Guram Karazanashvili's clinic
City
Tbilisi
Country
Georgia
Facility Name
Research Institute of Clinical Medicine
City
Tbilisi
Country
Georgia
Facility Name
Tsulukidze National Center of Urology
City
Tbilisi
Country
Georgia
Facility Name
Evaggelismos Hospital
City
Kolonaki
Country
Greece
Facility Name
Papageorgiou General Hospital
City
Thessaloníki
Country
Greece
Facility Name
Principal SMO Kft.
City
Baja
Country
Hungary
Facility Name
Jahn Ferenc South Pest Hospital, Department of Urology
City
Budapest
Country
Hungary
Facility Name
Petz Aladar County Teaching Hospital, Department of Urology
City
Gyor
Country
Hungary
Facility Name
Elisabeth Teaching Hospital and Rehabilitation Institute of Sopron, Department of Urology
City
Sopron
Country
Hungary
Facility Name
Csongrad County Dr. Bugyi Istvan Hospital, Department of Urology
City
Szentes
Country
Hungary
Facility Name
St. Borbala Hospital, Department of Urology
City
Tatabanya
Country
Hungary
Facility Name
Zion Medical Center
City
Haifa
Country
Israel
Facility Name
Hospital Mater Domini
City
Castellanza
Country
Italy
Facility Name
Liepajas Regional Hospital
City
Liepaja
Country
Latvia
Facility Name
P. Stradins Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
Riga East University Hospital, LLC
City
Riga
Country
Latvia
Facility Name
SIA 'URO' Clinic
City
Riga
Country
Latvia
Facility Name
Vidzemes Hospital
City
Valmiera
Country
Latvia
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
Country
Mexico
Facility Name
Hospital Civil Guadalajara Dr. Juan I. Mendoza
City
Guadalajara
Country
Mexico
Facility Name
National Scientific Practical Center for Emergency Medicine, Department of Urology
City
Chisinau
Country
Moldova, Republic of
Facility Name
Republican Clinical Hospital, Department of Urology
City
Chisinau
Country
Moldova, Republic of
Facility Name
Boni Fratres Catoviensis Sp. z o.o., Department of Internal Diseases with Cardiologic Diagnostics Unit
City
Katowice
Country
Poland
Facility Name
Military Medical Academy University Teaching Hospital - Central Veterans' Hospital, Clinical and Didactic Center of the Medical University of Lodz, Teaching Department of Nephrology, Hypertension and Renal Transplantation
City
Lodz
Country
Poland
Facility Name
Medicome Sp. z o.o.
City
Oswiecim
Country
Poland
Facility Name
HEUREKA Hanna Szalecka
City
Piaseczno
Country
Poland
Facility Name
Pope John Paul 2nd Independent Public Provincial Hospital
City
Zamość
Country
Poland
Facility Name
Emergency Clinical County Hospital Brasov
City
Brasov
Country
Romania
Facility Name
"Prof. Dr. Th. Burghele" Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
Delta Hospital
City
Bucharest
Country
Romania
Facility Name
Craiova Emergency Clinical County Hospital
City
Craiova
Country
Romania
Facility Name
Clinical Hospital "Dr. C. I. Parhon"
City
Iași
Country
Romania
Facility Name
Oradea Clinical Municipal Hospital "Dr. Gavril Curteanu"
City
Oradea
Country
Romania
Facility Name
Sibiu County Emergency Clinical Hospital
City
Sibiu
Country
Romania
Facility Name
Central Clinical Hospital of Civil Aviation
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital #57 under Moscow Healthcare Department
City
Moscow
Country
Russian Federation
Facility Name
Federal Clinical Center for High Medical Technologies
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital of Emergency Care #2
City
Novosibirsk
Country
Russian Federation
Facility Name
Penza Regional Clinical Hospital n.a. N.N. Burdenko
City
Penza
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
Country
Russian Federation
Facility Name
North-Western State Medical University n.a. I.I. Mechnikov
City
Saint Petersburg
Country
Russian Federation
Facility Name
Saint-Petersburg Scientific Research Institute for Phthisiopulmonology
City
Saint Petersburg
Country
Russian Federation
Facility Name
St. Petersburg Clinical Hospital under the Russian Academy of Sciences
City
Saint Petersburg
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution: City Hospital #15
City
Saint Petersburg
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution: St. George the Martyr City Hospital
City
Saint Petersburg
Country
Russian Federation
Facility Name
St. Petersburg State-Funded Healthcare Institution: City Hospital #26
City
Saint Petersburg
Country
Russian Federation
Facility Name
Saratov State Medical University n.a. V.I. Razumovsky
City
Saratov
Country
Russian Federation
Facility Name
Smolensk Regional Clinical Hospital
City
Smolensk
Country
Russian Federation
Facility Name
Novgorod Regional Clinical Hospital
City
Veliky Novgorod
Country
Russian Federation
Facility Name
Vsevolozhsk Clinical Central District Hospital
City
Vsevolozhsk
Country
Russian Federation
Facility Name
Lakeview Hospital
City
Benoni
Country
South Africa
Facility Name
Clinresco Centres
City
Kempton Park
Country
South Africa
Facility Name
Mzansi Ethical Research Centre
City
Middleburg
Country
South Africa
Facility Name
St. Georges Hospital
City
Port Elizabeth
Country
South Africa
Facility Name
Regional Municipal Institution "Chernivtsi Regional Hospital"
City
Chernivtsi
Country
Ukraine
Facility Name
Dnipropetrovsk City Multispecialty Clinical Hospital #4
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Ivano-Frankivsk City Clinical Hospital #1
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
O.I. Meschaninov Clinical Hospital of Emergency and Urgent Medical Care
City
Kharkiv
Country
Ukraine
Facility Name
Shapoval Regional Clinical Center of Urology and Nephrology
City
Kharkiv
Country
Ukraine
Facility Name
Khmelnytskyi Regional Hospital
City
Khmel'nyts'kyy
Country
Ukraine
Facility Name
Institute of Urology
City
Kyiv
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
L'viv
Country
Ukraine
Facility Name
Volyn Regional Clinical Hospital
City
Luts'k
Country
Ukraine
Facility Name
Mykolaiv Regional Hospital, Center for Nephrology and Dialysis
City
Mykolaiv
Country
Ukraine
Facility Name
City Clinical Hospital #10, Urology Department #1
City
Odesa
Country
Ukraine
Facility Name
Odesa Regional Clinical Hospital
City
Odessa
Country
Ukraine
Facility Name
Poltava M.V. Sklifosovskyi Regional Clinical Hospital
City
Poltava
Country
Ukraine
Facility Name
State Institution: Uzhhorod Railway Station Clinical Hospital under State Territorial Industry-Specific Association:Lviv Railway
City
Uzhhorod
Country
Ukraine
Facility Name
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
City
Vinnytsya
Country
Ukraine
Facility Name
Municipal Institution "Zaporizhzhia Reqional Clinical Hospital" of Zaporizhzhia Regional Councill
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

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Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections

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