Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections

This study is currently recruiting participants.
Verified April 2014 by Tetraphase Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01978938
First received: October 28, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Complicated Urinary Tract Infections (cUTI)
Drug: Eravacycline
Drug: Levofloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Tetraphase Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Clinical and microbiological response vs failure [ Time Frame: at the Post-Treatment (PT) visit (defined as 6-8 days after the completion of therapy) ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 840
Study Start Date: December 2013
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978938

Contacts
Contact: Kevin Lloyd 617-715-3589 klloyd@tphase.com

Locations
United States, California
San Diego Clinical Trials Recruiting
San Diego, California, United States, 92120
Principal Investigator: Mohamed Bidair, MD         
Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90505
Principal Investigator: Brad Spellberg, MD         
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Principal Investigator: David Orban, MD         
United States, Georgia
Columbus Regional Research Institute Recruiting
Columbus, Georgia, United States, 31904
Principal Investigator: David Subich, MD         
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: , MD         
Principal Investigator: Christian Jones, MD         
Sponsors and Collaborators
Tetraphase Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01978938     History of Changes
Other Study ID Numbers: TP-434-010
Study First Received: October 28, 2013
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 17, 2014