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NCT03580044 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT03580044: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT03580044 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03580044, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study Summary
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI), nosocomial pneumonia (NP) including hospital acquired pneumonia (HAP) and ventilator associated pneumonia (VAP), complicated urinary tract infections (cUTI), or bloodstream infections (BSI) due to metallo-β-lactamase (MBL)- producing Gram-negative bacteria.
Primary Outcome
Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% confidence interval (CI) was calculated using Jeffrey's method.
Interventions
- DRUG BAT
- COMBINATION_PRODUCT ATM-AVI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-12-25 |
| Est. Completion | 2023-01-23 |
| Phase | Phase 3 |
Why NCT03580044 stopped before completion
NCT03580044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which BAT is the first listed.
NCT03580044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03580044 about?
NCT03580044 is a clinical study titled "Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria". Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI), nosocomial pneumonia (NP) including hospital acquired pneumonia (HAP) a...
What is the current status of trial NCT03580044?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2020-12-25. Estimated completion is 2023-01-23.
What interventions are being tested in trial NCT03580044?
The interventions under investigation include: BAT (DRUG), ATM-AVI (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03580044?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03580044's enrollment target sits among peer trials
15 1977th of 2000 higher than 18 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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