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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
Sponsor:
Information provided by (Responsible Party):
Tetraphase Pharmaceuticals, Inc.

Brief Summary:
This is 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 (cUTI)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eravacycline IV and oral
Eravacycline 1.5 mg/kg IV q24h plus eravacycline 250 mg PO BID
Drug: Eravacycline
Active Comparator: Levofloxacin
Levofloxacin 750 mg PO QD + placebo PO QD
Drug: Levofloxacin
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
Drug: Eravacycline



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Male and female subjects with either:

    a. Pyelonephritis and normal urinary tract anatomy (no more than 30% of the total population), OR b. cUTI with at least one of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately 100 mL of residual urine after voiding) iii. Neurogenic bladder iv. Partial obstructive uropathy (eg, nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not CHF or volume related) such that the serum BUN is elevated (> 20 mg/dL) AND the serum BUN:creatinine ratio is < 15 vi. Surgically modified or abnormal urinary tract anatomy (eg, bladder diverticula, redundant urine collection system, etc.) EXCEPT surgery within the last month

Exclusion Criteria:

  • 1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in subjects with cUTI, including:

    1. Subjects with a history of a levofloxacin-resistant urinary tract infection
    2. Likely to receive ongoing antibacterial drug prophylaxis prior to the LPT visit (eg, subjects with vesiculo-ureteral reflux)

Information from the National Library of Medicine

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


  Show 57 Study Locations
Sponsors and Collaborators
Tetraphase Pharmaceuticals, Inc.

Responsible Party: Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01978938     History of Changes
Other Study ID Numbers: TP-434-010
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors