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NCT01844856 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

A Phase 3 study of Complicated Intra-abdominal Infections, sponsored by Tetraphase Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
541
Enrollment target
20
Study locations

NCT01844856: Completed Phase 3 study of Complicated Intra-abdominal Infections, sponsored by Tetraphase Pharmaceuticals.

NCT01844856 is a Phase 3 study of Complicated Intra-abdominal Infections that has completed, run by Tetraphase Pharmaceuticals. The registered enrollment target is 541 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01844856, a Phase 3 study of Complicated Intra-abdominal Infections, has completed, sponsored by Tetraphase Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
541 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

Primary Outcome

Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment wa

Interventions

  • DRUG Placebo
  • DRUG Eravacycline
  • DRUG Ertapenem

Study Locations (20)

California

  • - Glendale
  • - La Mesa
  • - Los Angeles
  • - Torrance

Ohio

  • - Cleveland
  • - Columbus
  • - Weston

Alabama

  • - Florence
  • - Mobile

Massachusetts

  • - Boston
  • - Springfield

New Jersey

  • - Camden
  • - Teaneck

Illinois

  • - Aurora

Indiana

  • - Carmel

Minnesota

  • - Minneapolis

Trial Details

FieldValue
Enrollment Target 541 participants
Start Date 2013-08
Est. Completion 2014-08
Phase Phase 3
Tetraphase Pharmaceuticals

13 total trials

What the finished NCT01844856 record still lists

NCT01844856 is an interventional study that assigns participants to a tested intervention. The registered 541 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 (30% lower).

The record links to 1 condition, with Complicated Intra-abdominal Infections appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01844856 names 20 study sites across 12 states, led by California, Ohio, Alabama.

Frequently Asked Questions

What is clinical trial NCT01844856 about?

NCT01844856 is a clinical study titled "Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections". This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

What is the current status of trial NCT01844856?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 541 participants. The study started on 2013-08. Estimated completion is 2014-08.

What conditions does trial NCT01844856 study?

This clinical trial studies the following conditions: Complicated Intra-abdominal Infections.

What interventions are being tested in trial NCT01844856?

The interventions under investigation include: Placebo (DRUG), Eravacycline (DRUG), Ertapenem (DRUG).

Who is sponsoring clinical trial NCT01844856?

This trial is sponsored by Tetraphase Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01844856 being conducted?

This trial has 20 study locations across Alabama, California, Illinois, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01844856's enrollment target sits among peer trials

541 694th of 2000 higher than 1,307 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 NCT01844856, the US trial registry maintained by the National Library of Medicine. NCT01844856 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.