Phase 3 N=908 Randomized Triple-blind Treatment

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

cUTI

Bottom Line

View on ClinicalTrials.gov: NCT01978938 ↗

Enrolled (actual)

908

Serious AEs

1.4%

Results posted

Dec 2018

Primary outcome: Primary: Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit — 180; 202; 100; 91 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Eravacycline (Drug); Levofloxacin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tetraphase Pharmaceuticals, Inc
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit	180; 202; 100; 91; 18; 9	—
SECONDARY Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response	194; 213; 85; 78; 18; 11	—
SECONDARY Participants In The Microbiologically Evaluable (ME) Population With A Microbiological Response	180; 203; 75; 73	—

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 participants with complicated urinary tract infections (cUTI).

Eligibility Criteria

Inclusion Criteria

Male and female participants with either:

a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR b. cUTI with at least 1 of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately 100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not congestive heart failure or volume related) such that the serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN: creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as, bladder diverticula, redundant urine collection system) EXCEPT surgery within the last month

Exclusion Criteria

Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in participants with cUTI, including:
Participants with a history of a levofloxacin-resistant urinary tract infection
Likely to receive ongoing antibacterial drug prophylaxis prior to the late Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01978938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.