Clinical Trial: Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-a

Brief Summary: This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

Detailed Summary:
Sponsor: Tetraphase Pharmaceuticals, Inc.

Current Primary Outcome: Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population [ Time Frame: TOC visit: 25-31 days after the first dose of study drug ]

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], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.


Original Primary Outcome: Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population [ Time Frame: TOC: 25-31 days after the first dose of study drug ]

Current Secondary Outcome:

  • Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit [ Time Frame: TOC visit: 25-31 days after first dose ]
    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], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
  • Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit [ Time Frame: TOC visit: 25-31 days after first dose ]
    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], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.


Original Secondary Outcome:

  • Clinical response of eravacycline and ertapenem treatment arms at the end-of-treatment (EOT), TOC, and follow-up(FU) visits [ Time Frame: EOT: within 24 hours of last dose; TOC: 25-31 days after first dose; FU: 38-50 days after first dose ]
    Compare clinical response in the following populations: 1) Intent -to-treat (ITT) population, 2) Clinically evaluable (CE) population, 3) Micro-ITT population (for EOT, FU), 4) Microbiologically evaluable (ME) population.
  • Microbiologic response of eravacycline and ertapenem treatment arms at the EOT and TOC visits [ Time Frame: EOT: within 24 hours of last dose; TOC: 25-31 days after first dose ]
    Compare the microbiological response in the following populations: 1) Micro-ITT population, 2) ME population.
  • Assess safety and tolerability of eravacycline (Adverse Events, Physical Exams, Vital signs, ECGs, Lab Data) in the safety population [ Time Frame: Screening, Days 1-14, EOT, TOC, FU ]
    Describe the safety profile of eravacycline
  • Explore pharmacokinetic parameters after eravacycline infusion [ Time Frame: Day 1 ]
    Evaluate the pharmacokinetics of eravacycline


Information By: Tetraphase Pharmaceuticals, Inc.

Dates:
Date Received: April 29, 2013
Date Started: August 2013
Date Completion:
Last Updated: February 29, 2016
Last Verified: February 2016