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NCT03329092 · ClinicalTrials.gov registry record · Phase 3

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.

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
422
Enrollment target

NCT03329092: Completed Phase 3 study, sponsored by Pfizer.

NCT03329092 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 422 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03329092, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
422 participants
Enrollment target

Study 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.

Primary Outcome

Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% confidence interval (CI) was based on Jeffrey's method.

Interventions

  • DRUG ATM-AVI
  • DRUG MTZ
  • DRUG MER
  • DRUG COL

Trial Details

FieldValue
Enrollment Target 422 participants
Start Date 2018-04-05
Est. Completion 2023-02-23
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT03329092 record still lists

NCT03329092 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).

The record links to 0 conditions, and to 4 interventions - of which ATM-AVI is the first listed.

NCT03329092 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03329092 about?

NCT03329092 is a clinical study titled "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.". 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.

What is the current status of trial NCT03329092?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 422 participants. The study started on 2018-04-05. Estimated completion is 2023-02-23.

What interventions are being tested in trial NCT03329092?

The interventions under investigation include: ATM-AVI (DRUG), MTZ (DRUG), MER (DRUG), COL (DRUG).

Who is sponsoring clinical trial NCT03329092?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03329092's enrollment target sits among peer trials

422 886th of 2000 higher than 1,111 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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Source: ClinicalTrials.gov NCT03329092, the US trial registry maintained by the National Library of Medicine. NCT03329092 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.