Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
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|ClinicalTrials.gov Identifier: NCT01978938|
Recruitment Status : Unknown
Verified May 2016 by Tetraphase Pharmaceuticals, Inc..
Recruitment status was: Active, not recruiting
First Posted : November 8, 2013
Last Update Posted : May 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Complicated Urinary Tract Infections (cUTI)||Drug: Eravacycline Drug: Levofloxacin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||840 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||September 2015|
Experimental: Eravacycline IV and oral
Eravacycline 1.5 mg/kg IV q24h plus eravacycline 250 mg PO BID
Active Comparator: Levofloxacin
Levofloxacin 750 mg PO QD + placebo PO QD
Other Name: Levaquin
Experimental: Eravacycline 1.5 mg/kg, plus eravacycline 200 mg PO
Eravacycline 1.5 mg/kg IV q24h plus eravacycline 200 mg PO BID
- Clinical and microbiological response vs failure [ Time Frame: at the Post-Treatment (PT) visit (defined as 6-8 days after the completion of therapy) ]
The primary objective is to demonstrate that eravacycline is non-inferior to levofloxacin in responder outcome (clinical and microbiological response vs failure) in the micro-ITT population at the Post-Treatment (PT) visit (defined as 6-8 days after the completion of therapy).
NOTE: For the EMA, the primary analysis populations will be the microbiologically evaluable (ME) and clinically evaluable (CE) populations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978938
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