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NCT01445678 · ClinicalTrials.gov registry record · Phase 3

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections

A Phase 3 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Completed
Registry status
Phase 3
Development phase
494
Enrollment target

NCT01445678: Completed Phase 3 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

NCT01445678 is a Phase 3 study that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 494 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01445678, a Phase 3 study, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

COMPLETED
Registry status
Phase 3
Development phase
494 participants
Enrollment target

Study Summary

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections (cIAI).

Primary Outcome

Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.

Interventions

  • DRUG Meropenem
  • DRUG CXA-201 and metronidazole

Trial Details

FieldValue
Enrollment Target 494 participants
Start Date 2011-12-23
Est. Completion 2013-10-15
Phase Phase 3

What the finished NCT01445678 record still lists

NCT01445678 is an interventional study that assigns participants to a tested intervention. The registered 494 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 (36% lower).

The record links to 0 conditions, and to 2 interventions - of which Meropenem is the first listed.

NCT01445678 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01445678 about?

NCT01445678 is a clinical study titled "Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections". This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections (cIAI).

What is the current status of trial NCT01445678?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2011-12-23. Estimated completion is 2013-10-15.

What interventions are being tested in trial NCT01445678?

The interventions under investigation include: Meropenem (DRUG), CXA-201 and metronidazole (DRUG).

Who is sponsoring clinical trial NCT01445678?

This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01445678's enrollment target sits among peer trials

494 779th of 2000 higher than 1,222 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 NCT01445678, the US trial registry maintained by the National Library of Medicine. NCT01445678 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.