Overview

This trial is active, not recruiting.

Condition complicated urinary tract infections (cuti)
Treatments eravacycline, levofloxacin
Phase phase 3
Sponsor Tetraphase Pharmaceuticals, Inc.
Start date December 2013
End date September 2015
Trial size 840 participants
Trial identifier NCT01978938, TP-434-010

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Eravacycline 1.5 mg/kg IV q24h plus eravacycline 250 mg PO BID
eravacycline
(Active Comparator)
Levofloxacin 750 mg PO QD + placebo PO QD
levofloxacin Levaquin
(Experimental)
Eravacycline 1.5 mg/kg IV q24h plus eravacycline 200 mg PO BID
eravacycline

Primary Outcomes

Measure
Clinical and microbiological response vs failure
time frame: at the Post-Treatment (PT) visit (defined as 6-8 days after the completion of therapy)

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Tetraphase Pharmaceuticals, Inc..