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NCT01147640 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections

A Phase 2 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Completed
Registry status
Phase 2
Development phase
122
Enrollment target

NCT01147640 is a Phase 2 study that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 122 participants.

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The verdict

NCT01147640, a Phase 2 study, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

COMPLETED
Registry status
Phase 2
Development phase
122 participants
Enrollment target

Study Summary

A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subjects with mild renal impairment are not necessary and subjects with more severe degrees of renal failure are excluded.

Interventions

  • DRUG CXA-101/ tazobactam and metronidazole
  • DRUG meropenem plus saline placebo

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2010-06-25
Est. Completion 2011-03-25
Phase Phase 2

What the Registry Record Tells You About NCT01147640

The ClinicalTrials.gov registry entry for NCT01147640 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which CXA-101/ tazobactam and metronidazole is the first listed.

NCT01147640 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01147640 about?

NCT01147640 is a clinical study titled "Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections". A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subject...

What is the current status of trial NCT01147640?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2010-06-25. Estimated completion is 2011-03-25.

What interventions are being tested in trial NCT01147640?

The interventions under investigation include: CXA-101/ tazobactam and metronidazole (DRUG), meropenem plus saline placebo (DRUG).

Who is sponsoring clinical trial NCT01147640?

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.