At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 143 enrolled
Drug / intervention
TP-434 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating TP-434, Ertapenem, and 1 other intervention for Complicated Intra-abdominal Infection. Completed, enrolled 143 participants across 38 sites in 6 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Intra-abdominal Infection
CountriesBulgaria, India, Latvia, Lithuania, Romania, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartJan 2011
Primary CompletionMay 2012
TodayJul 2026
First PostedDec 23, 2010
Enrollment StartJan 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.5 years ago
Interventions
TP-434drug
Ertapenemdrug
Placebodrug
Administered IV to maintain the blind.