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Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections

NCT01265784 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2022-01-06

Study results available
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Summary

This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).

Conditions

  • Complicated Intra-abdominal Infection

Interventions

DRUG

TP-434

DRUG

Ertapenem

DRUG

Placebo

Administered IV to maintain the blind.

Sponsors & Collaborators

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Patrick T Horn, MD, PhD · Tetraphase Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States
  • Bulgaria
  • India
  • Latvia
  • Lithuania
  • Romania

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 NCT01265784 on ClinicalTrials.gov