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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
143
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit
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 \[cIAI\], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure \[TOC\] assessment was not available, death unrelated to cIAI, or some other reason).
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit
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Long Beach VA Medical Center
Long Beach, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Henry Ford Hospital
Detroit, Michigan, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Mercury Street Medical Group
Butte, Montana, United States
MHAT "Yulia Vrevska - Byala" EOOD, Byala
Byala, Bulgaria
UMHAT "Dr. Georgi Stranski" EAD, Pleven
Pleven, Bulgaria
UMHAT "Sveti Georgi" EAD, Plovdiv
Plovdiv, Bulgaria
MHAT "Russe" AD, Russe
Rousse, Bulgaria
MHAT "Tokuda Hospital Sofia" AD, Sofia
Sofia, Bulgaria
...and 28 more locations
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit
Time frame: Follow-Up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit
Time frame: Follow-up Visit (28-42 days after last dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit
Microbiological response was classified as favorable (eradication or presumed eradication), unfavorable (persistence, presumed persistence, superinfection, or new infection), or indeterminate (assessment not possible).
Time frame: EOT Visit (4-14 days after first dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit
Time frame: EOT Visit (4-14 days after first dose of study drug)
Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit
Time frame: TOC Visit (10-14 days after last dose of study drug)
Pharmacokinetics: Maximum Concentration (Cmax) of TP-434
Time frame: Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion
Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434
Time frame: Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion