Clinical Trial: Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-A

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.

Detailed Summary:
Sponsor: Paratek Pharmaceuticals Inc

Current Primary Outcome:

  • Number of subjects with clinical success at the early clinical response assessment visit as defined by survival with improvement on 2 of 4 symptoms of community acquired bacterial pneumonia (CABP) [ Time Frame: 72-120 hours after first dose of study drug ]
    Symptoms include cough, sputum production, pleuritic chest pain and dyspnea
  • Number of subjects with clinical success at the post treatment evaluation visit defined as survival after test article completion and symptom resolution [ Time Frame: 5-10 days after the last day of therapy ]
    Symptoms include cough, sputum production, pleuritic chest pain and dyspnea


Original Primary Outcome:

  • Number of subjects with clinical success at the early clinical response assessment visit as defined by survival with improvement on 2 of 4 symptoms of community acquired bacterial pneumonia (CABP) [ Time Frame: 72 hours after first dose of study drug ]
    Symptoms include cough, sputum production, pleuritic chest pain and dyspnea
  • Number of subjects with clinical success at the post treatment evaluation visit defined as survival after test article completion and symptom resolution [ Time Frame: 5-10 days after the last day of therapy ]
    Symptoms include cough, sputum production, pleuritic chest pain and dyspnea


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Paratek Pharmaceuticals Inc

Dates:
Date Received: July 14, 2015
Date Started: November 2015
Date Completion: February 2017
Last Updated: January 24, 2017
Last Verified: January 2017