Clinical trial NCT03329092: 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.
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Innovative Medicines Initiative
name: Biomedical Advanced Research and Development Authority
First posted: 2017-11-01
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Multicenter, Open Label, Central Assessor Blinded, Parallel Group, Comparative Study
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Intent-To-Treat (ITT) Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Clinical Cure at TOC Visit: Clinically Evaluable (CE) Analysis Set
timeFrame: At TOC visit (Day 28)
Secondary outcomes:
measure: Percentage of Participants With Clinical Cure at TOC Visit: Microbiological Intent-To-Treat (Micro-ITT) Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Clinical Cure at TOC Visit: Microbiologically Evaluable (ME) Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Clinical Cure at TOC Visit by Type of Infection: ITT Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Clinical Cure at TOC Visit by Type of Infection: CE Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Clinical Cure in Participants With Metallo-beta-lactamase (MBL) Positive Pathogen at TOC Visit: Micro-ITT Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Clinical Cure in Participants With MBL Positive Pathogen at TOC Visit: ME Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit: Micro- ITT Analysis Set
timeFrame: At TOC visit day (28)
measure: Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit: ME Analysis Set
timeFrame: At TOC Visit (Day 28)
measure: Percentage of Participants Who Died on or Before 28 Days After Randomization: ITT Analysis Set
timeFrame: From randomization up to 28 days
measure: Percentage of Participants Who Died on or Before 28 Days After Randomization: Micro-ITT Analysis Set
timeFrame: From randomization up to 28 days
measure: Plasma Concentration of Aztreonam
timeFrame: Anytime between 25 to 30 minutes, 3.25 to 3.5 hours, 5.5 to 6.5 hours, 7.5 to 8.5 hours post start of infusion on Day 1; 2.75 to 3 hours, 3.5 to 4.5 hours, 5 to 6 and 7 to 8 hours post start of infusion on Day 4
measure: Plasma Concentration of Avibactam
timeFrame: Anytime between 25 to 30 minutes, 3.25 to 3.5 hours, 5.5 to 6.5 hours, 7.5 to 8.5 hours post start of infusion on Day 1; 2.75 to 3 hours, 3.5 to 4.5 hours, 5 to 6 and 7 to 8 hours post start of infusion on Day 4
measure: Maximum Plasma Concentration for a Dosing Interval at Steady-State (Cmax, ss) According to Clinical Response by Infection Type at TOC: Aztreonam
timeFrame: At TOC (Day 28)
measure: Percentage of Time That Free Plasma Concentrations Are Above the Minimum Inhibitory Concentration Over a Dosing Interval (%fT>MIC Aztreonam (ATM) of 8 mg/L) According to Clinical Response by Infection Type at TOC: Aztreonam
timeFrame: At TOC (Day 28)
measure: Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss ) According to Clinical Response by Infection Type at TOC: Aztreonam
timeFrame: 0 to 24 hours at TOC (Day 28)
measure: Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss) According to Microbiological Response by Infection Type at TOC: Aztreonam
timeFrame: At TOC (Day 28)
measure: Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Microbiological Response by Infection Type at TOC: Aztreonam
timeFrame: 0 to 24 hours at TOC (Day 28)
measure: Percentage of Time That Free Plasma Concentrations Are Above the Minimum Inhibitory Concentration Over a Dosing Interval (%fT>MIC Aztreonam (ATM) of 8 mg/L) According to Microbiological Response by Infection Type at TOC: Aztreonam
timeFrame: At TOC (Day 28)
measure: Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Clinical Response by Infection Type at TOC: Avibactam
timeFrame: 0 to 24 hours at TOC (Day 28)
measure: Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss ) According to Clinical Response by Infection Type at TOC: Avibactam
timeFrame: At TOC (Day 28)
measure: Percent of Time That Free Plasma Concentrations Are Above the Threshold Concentration Over a Dosing Interval (%fT>CT of 2.5mg/L) According to Clinical Response by Infection Type at TOC: Avibactam
timeFrame: At TOC (Day 28)
measure: Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Microbiological Response by Infection Type at TOC: Avibactam
timeFrame: 0 to 24 hours At TOC (Day 28)
measure: Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss (mg/L)) According to Microbiological Response by Infection Type at TOC: Avibactam
timeFrame: At TOC (Day 28)
measure: Percent of Time That Free Plasma Concentrations Are Above the Threshold Concentration Over a Dosing Interval; (%fT>CT of 2.5 mg/L) According to Microbiological Response by Infection Type at TOC: Avibactam
timeFrame: At TOC (Day 28)
measure: Number of Participants With Adverse Events (AEs) and Serious AEs
timeFrame: From start of study treatment until end of late follow-up (Up to Day 45)
measure: Number of Participants With Potentially Clinically Significant Hematology Abnormalities
timeFrame: From start of study treatment until TOC visit (Up to Day 28)
measure: Number of Participants With Potentially Clinically Significant Clinical Chemistry Abnormalities
timeFrame: From start of study treatment until At TOC visit (Up to Day 28)
measure: Number of Participants With Abnormalities in Vital Signs
timeFrame: From start of study treatment until TOC visit (Up to Day 28)
measure: Number of Participants With Abnormal Physical Examination Finding
timeFrame: Screening, End of treatment (up to 24 hours post infusion on Day 14) and Test of Cure (Day 28)
measure: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Baseline (latest non-missing value before start of treatment) and Day 3
Other outcomes:
measure: Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit: ITT Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Clinical Cure at EOT Visit: Micro-ITT Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Clinical Cure at EOT Visit: CE Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Clinical Cure at EOT Visit: ME Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Clinical Cure by Type of Infection at EOT Visit: ITT Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Clinical Cure by Type of Infection at EOT Visit: CE Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 24)
measure: Percentage of Participants With Clinical Cure by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Clinical Cure by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set
timeFrame: At TOC (Day 28)
measure: Percentage of Participants With Clinical Cure by Pathogen Resistance Type at EOT Visit: ME Analysis Set
timeFrame: At EOT (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Clinical Cure by Pathogen Resistance Type at TOC Visit: ME Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Favorable Per Participant Microbiological Response at EOT Visit: Micro-ITT Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Favorable Per Participant Microbiological Response at EOT Visit : ME Analysis Set
timeFrame: At EOT visit (Within 24 hours after last infusion on Day 14)
measure: Number of Participants With Favorable Microbiological Response Per-Pathogen at EOT Visit: Micro-ITT Analysis Set
timeFrame: At EOT (Within 24 hours after last infusion on Day 14)
measure: Number of Participants With Favorable Microbiological Response Per-Pathogen at at TOC Visit: Micro-ITT Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Number of Participants With Favorable Microbiological Response Per-Pathogen at EOT Visit: ME Analysis Set
timeFrame: At EOT (Within 24 hours after last infusion on Day 14)
measure: Number of Participants With Favorable Microbiological Response Per-Pathogen at TOC Visit: ME Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set
timeFrame: At EOT (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at EOT Visit: ME Analysis Set
timeFrame: At EOT (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at TOC Visit: ME Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set
timeFrame: At EOT (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at EOT Visit: ME Analysis Set
timeFrame: At EOT (Within 24 hours after last infusion on Day 14)
measure: Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at TOC Visit: ME Analysis Set
timeFrame: At TOC visit (Day 28)
measure: Number of Participants According to Total Score for the Composite Endpoint of Symptom-Based Objective Clinical Measures: ITT Analysis Set
timeFrame: Up to Day 28
measure: Number of Participants According to Total Score for the Composite Endpoint of Symptom-Based Objective Clinical Measures: CE Analysis Set
timeFrame: Up to Day 28
measure: Percentage of Participants Who Died on or Before 14 Days From Randomization: ITT Analysis Set
timeFrame: From randomization up to 14 days
measure: Total Length of Hospital Stay up to TOC Visit: ITT Analysis Set
timeFrame: From randomization up to Day 28
measure: Total Length of Hospital Stay up to TOC Visit: CE Analysis Set
timeFrame: From randomization up to Day 28
measure: Duration of Study Treatment
timeFrame: From first dose of study treatment until last dose of treatment (Up to 14 days)
measure: Length of Intensive Care Unit (ICU) Stay: ITT Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Length of Intensive Care Unit (ICU) Stay: CE Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Number of Participants Admitted to the ICU: ITT Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Number of Participants Admitted to the ICU: CE Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Number of Participants With Mechanical Ventilation: ITT Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Number of Participants With Mechanical Ventilation: CE Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Duration of Mechanical Ventilation in HAP/VAP Participants: ITT Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Duration of Mechanical Ventilation in HAP/VAP Participants: CE Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Number of Participants With Unplanned Surgical Interventions in Complicated Intra-abdominal Infections (cIAI) Participants: ITT Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
measure: Number of Participants With Unplanned Surgical Interventions in cIAI Participants: CE Analysis Set
timeFrame: From randomization until TOC visit (Up to Day 28)
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center - Tucson
state: Arizona
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Rosario
country: Argentina
facility: Sanatorio Britanico
state: Santa FE
city: Santo Tome
country: Argentina
facility: Sanatorio Servicios Medicos SM
state: Santa FE
city: Córdoba
country: Argentina
facility: Hospital San Roque
city: Sofia
country: Bulgaria
facility: University Hospital Alexandrovska, Clinic of Anesthesiology and Intensive Care
city: Sofia
country: Bulgaria
facility: University Hospital Queen Joanna ISUL, Clinic of Surgery
city: Stara Zagora
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment ''Prof.Dr Stoyan Kirkovich''AD
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
city: Nanning
country: China
facility: Nanning First People's Hospital
state: Guangxi Zhuang Autonomous Region
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Changsha
country: China
facility: Changsha Third Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Province People's Hospital
state: Hunan
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia Autonomous Region
city: Jiangyin
country: China
facility: Jiangyin People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Kunming
country: China
facility: The First people's Hospital of Kunming
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking University People's Hospital
city: Jiangyin
country: China
facility: Jiangyin People's Hospital
city: Tianjin
country: China
facility: Tianjin Union Medical Center
city: Zagreb
country: Croatia
facility: Klinicka bolnica Merkur
state: GRAD Zagreb
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka
state: Primorsko-goranska Zupanija
city: Osijek
country: Croatia
facility: University Hospital Centre Osijek
city: Slavonski Brod
country: Croatia
facility: General Hospital "Dr. Josip Bencevic" Slavonski Brod
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Decin
country: Czechia
facility: Krajska zdravotni, a.s. - Nemocnice Decin, o.z.
city: Decin
country: Czechia
facility: Lekarna Nemocnice Decin, Krajska zdravotni, a.s.- Nemocnice Decin, o.z.
city: Kolin III
country: Czechia
facility: Public Hospital Kolin, a.s.
city: Kyjov
country: Czechia
facility: Nemocnice Kyjov, prispevkova organizace
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Athens
country: Greece
facility: General Hospital of Athens "Evangelismos"
city: Athens
country: Greece
facility: General and Chest Diseases Hospital "Sotiria"
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
city: Athens
country: Greece
facility: University General Hospital "ATTIKON"
city: Heraklion, Crete
country: Greece
facility: University General Hospital of Heraklion
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Larissa
country: Greece
facility: Koutlimbaneio and Triantafylleio General Hospital of Larissa
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Bangalore
country: India
facility: Victoria Hospital, Bangalore Medical College and Research Institute
state: Karnataka
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Hospitals
state: Karnataka
city: Manipal
country: India
facility: Kasturba Medical College and Hospital
state: Karnataka
city: Mysuru
country: India
facility: JSS Hospital
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences & Research Centre
state: Kerala
city: Kozhikode
country: India
facility: Government Medical College, Kozhikode
state: Kerala
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital And Research Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Specialty Hospital
state: Maharashtra
city: Jaipur
country: India
facility: S.R. Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Chennai
country: India
facility: Apollo Hospitals
state: Tamil NADU
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital
city: Pune
country: India
facility: Sahyadri Clinical Research & Development Center
city: Pune
country: India
facility: Sahyadri Specialty Hospital
city: Ashdod
country: Israel
facility: Assuta Ashdod University Hospital
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Zerifin
country: Israel
facility: Shamir Medical Center, Infectious Diseases Unit
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
state: Milan
city: Foggia
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena
city: Modena
country: Italy
facility: Farmacia Ospedaliera - Direzione Assistenza Farmaceutica
city: Modena
country: Italy
facility: SC di Radiologia - Azienda Ospedaliera Universitaria di Modena
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
city: Pisa
country: Italy
facility: UO Radiognastostica 2 Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
city: Pisa
country: Italy
facility: UO Farmaceutica Azienda Ospedaliero-Universitaria Pisana
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center - Infectious Disease
state: Incheon Gwang'yeogsiv
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seberang Jaya
country: Malaysia
facility: Hospital Seberang Jaya
state: Pulau Pinang
city: Kuala Terengganu
country: Malaysia
facility: Hospital Sultanah Nur Zahirah
state: Terengganu
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo LEON
city: City Of Dasmarinas
country: Philippines
facility: De La Salle Medical and Health Sciences Institute
state: Cavite
city: Baguio City
country: Philippines
facility: Baguio General Hospital and Medical Center
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Iloilo City
country: Philippines
facility: St. Paul's Hospital of Iloilo, Inc.
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: Philippine General Hospital, Central Intensive Care Unit
city: Muntinlupa City
country: Philippines
facility: Asian Hospital and Medical Center
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Bucuresti
country: Romania
facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Boli Infectioase si tropicale "Dr. Victor Babes"
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Boli Infectioase Cluj-Napoca
city: Iasi
country: Romania
facility: Spitalul Clinic de Boli Infectioase "Sf. Parascheva" Iasi
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
city: Chelyabinsk
country: Russian Federation
facility: Private Healthcare Institution "Clinical Hospital 'Russian Railroad Medicine, Chelyabinsk'"
city: Krasnodar
country: Russian Federation
facility: State Budgetary Healthcare Institution "Regional Clinical Hospital No. 2" of the Ministry of Health
city: Novosibirsk
country: Russian Federation
facility: GBUZ of Novosibirsk region "City Clinical Hospital # 2"
city: Perm
country: Russian Federation
facility: State autonomous institution of healthcare of the Perm Region" City clinical hospital #4"
city: Saint-Petersburg
country: Russian Federation
facility: FGBOU VO "The First St. Petersburg state medical university n. a. I.P. Pavlova"
city: Smolensk
country: Russian Federation
facility: OGBUZ "Smolensk Regional Clinical Hospital"
city: Smolensk
country: Russian Federation
facility: FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF
city: Smolensk
country: Russian Federation
facility: Scientific Research Institute of Antimicrobial Chemotherapy
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
state: Barcelona
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Parc de Salut Mar- Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic la Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Douliou
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
state: Yunlin
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
city: Muang
country: Thailand
facility: Srinagarind Hospital, Division of Infectious Disease and Tropical Medicine
state: Khon Kaen
city: Muang
country: Thailand
facility: Bamrasnaradura Infectious Disease Institute (BIDI)
state: Nonthaburi
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital, Prince of Songkla University
state: Songkhla
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
city: Ankara
country: Turkey
facility: T.C. Saglik Bakanligi Ankara Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Acibadem Atakent Hospital
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
city: Izmir
country: Turkey
facility: Ege University Faculty of Medicine
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medical Faculty Farabi Hospital
city: Chernivtsi
country: Ukraine
facility: OKU "Chernivetska oblasna klinichna likarnia", khirurhichne viddilennia
city: Dnipro
country: Ukraine
facility: KZ "Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova", viddilennia khirurhii №2
city: Dnipro
country: Ukraine
facility: Komunalnyi zaklad "Miska klinichna likarnia No.4" Dniprovskoi miskoi rady, viddilennia profpatolohii
city: Ivano-Frankivsk
country: Ukraine
facility: Oblasna klinichna likarnia, viddilennia anesteziolohii ta intensyvnoi terapii
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivska tsentralna miska klin likarnia, viddilennia khirurhii,
city: Kharkiv
country: Ukraine
facility: DU "Instytut zahalnoi ta nevidkladnoi khirurhii imeni V.T. Zaitseva Natsionalnoi akademii medychnykh
city: Kyiv
country: Ukraine
facility: Kyivska miska klinichna likarnia No. 3, khirurhichne viddilennia
city: Kyiv
country: Ukraine
facility: Kyivska miska klinichna likarnia #4, khirurhichne viddilennia #1
city: Lviv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia
city: Odesa
country: Ukraine
facility: Odeska klinichna likarnia na zaliznychnomu transporti filii "Tsentr okhorony zdorovia" aktsionernoho
city: Poltava
country: Ukraine
facility: Komunalne pidpryiemstvo "1-a miska klinichna likarnia Poltavskoi miskoi rady",
city: Vinnytsia
country: Ukraine
facility: Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: