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

NCT02784704 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-01-06

Study results available
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Summary

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

Conditions

  • Complicated Intra-abdominal Infections
  • Complicated Appendicitis

Interventions

DRUG

Eravacycline

DRUG

Meropenem

DRUG

Placebo

Sponsors & Collaborators

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Tetraphase Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-13
Primary Completion
2017-05-08
Completion
2017-05-19

Countries

  • United States
  • Bulgaria
  • Czechia
  • Estonia
  • Georgia
  • Hungary
  • Latvia
  • Lithuania
  • Romania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02784704 on ClinicalTrials.gov