NCT01265784

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

A Phase 2, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety, and PK of 2 Dose Regimens of TP-434 Compared With Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Tetraphase Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	TP-434
DRUG	Ertapenem
DRUG	Placebo	Administered IV to maintain the blind.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-12-23
• Last updated: 2022-01-06
• Results posted: 2015-09-04

Locations

38 sites across 6 countries: United States, Bulgaria, India, Latvia, Lithuania, Romania