A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria. (REVISIT)
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
Sponsor: Biomedical Advanced Research and Development Authority
A PHASE3 clinical study on Complicated Intra-abdominal Infection and Hosptial Acquired Pneumonia, this trial is completed. The trial is conducted by Biomedical Advanced Research and Development Authority and has accumulated 60 data snapshots since 2018. Infectious disease trials contribute critical data for public health response and treatment development.
Status Flow
Change History
60 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Feb 2025 — Sep 2025 [monthly]
Completed PHASE3
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Jan 2025 — Feb 2025 [monthly]
Completed PHASE3
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Sep 2024 — Jan 2025 [monthly]
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Completed PHASE3
▶ Show 55 earlier versions
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Completed PHASE3
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Completed PHASE3
Status: Active Not Recruiting → Completed
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Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Recruiting PHASE3
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Status: Suspended → Recruiting
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Sep 2020 — Oct 2020 [monthly]
Suspended PHASE3
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Jul 2020 — Sep 2020 [monthly]
Suspended PHASE3
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Jun 2020 — Jul 2020 [monthly]
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Nov 2018 — Jan 2019 [monthly]
Suspended PHASE3
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Oct 2018 — Nov 2018 [monthly]
Suspended PHASE3
Status: Recruiting → Suspended
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Sep 2018 — Oct 2018 [monthly]
Recruiting PHASE3
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Aug 2018 — Sep 2018 [monthly]
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Jul 2018 — Aug 2018 [monthly]
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May 2018 — Jun 2018 [monthly]
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Status: Not Yet Recruiting → Recruiting
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Mar 2018 — May 2018 [monthly]
Not Yet Recruiting PHASE3
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Dec 2017 — Mar 2018 [monthly]
Not Yet Recruiting PHASE3
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Nov 2017 — Dec 2017 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Biomedical Advanced Research and Development Authority
- Innovative Medicines Initiative
- Pfizer
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Ankara, Turkey (Türkiye) , Ashdod, Israel , Athens, Greece , Badalona, Spain , Baguio City, Philippines , Bangalore, India , Bangkoknoi, Thailand , Baotou, China , Barcelona, Spain , Beijing, China and 107 more locations