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

Completed · Phase 3

Conditions studied: cUTI

In brief

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).

Key facts

Study ID

NCT01978938

Run by

Tetraphase Pharmaceuticals, Inc

People needed

908

Starts

2014-10-06

Expected to finish

2015-08-21

Last updated by the study team

2022-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Harbor-UCLA Medical Center — Torrance, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Sunrise Hospital and Medical Centre — Las Vegas, Nevada, United States
• Columbus Regional Research Institute — Columbus, Ohio, United States
• Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Nephrology — Gabrovo, Bulgaria
• Multiprofile Hospital for Active Treatment "Dr. Stamen Iliev", Montana, Department of Nephrology and Dialysis — Montana, Bulgaria
• University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic — Pleven, Bulgaria
• Multiprofile Hospital for Active Treatment, Ruse, Department of Urology — Rousse, Bulgaria
• Multiprofile Hospital for Active Treatment, Sofia at Military Medical Academy, General Urology Clinic — Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Department of Laparoscopic Urology — Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic — Sofia, Bulgaria
• Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology — Veliko Tarnovo, Bulgaria
• Fundacion Cardiomet — Armenia, Colombia
• De la Costa Clinic. Ltd. Research Centre — Barranquilla, Colombia
• University Hospital Brno, Clinic of Urology — Brno, Czechia
• University Hospital Hradec Kralove, Clinic of Urology — Hradec Králové, Czechia
• Hospital Novy Jicin, Department of Urology — Nový Jičín, Czechia
• University Hospital Olomouc — Olomouc, Czechia
• Thomayer Hospital, Department of Urology — Prague, Czechia
• East Viru Central Hospital, Surgery Clinic — Kohtla-Järve, Estonia
• East Tallinn Central Hospital, Department of Internal Medicine — Tallinn, Estonia
• West Tallinn Central Hospital, Department of Urology — Tallinn, Estonia
• Tartu University Hospital, Surgery Clinic, Department of Urology and Renal Transplantation — Tartu, Estonia
• San Diego Clinical Trials — San Diego, California, United States

Full record on ClinicalTrials.gov

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