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IT00l-302


Title IT00l-302: A prospective, phase 3, randomized, multi-center, double-blind, double-dummy study of the efficacy, tolerability, and safety of intravenous sulopenem followed by oral sulopenem­etzadroxil with probenecid versus intravenous ertapenem followed by oral ciprofloxacin or amoxicill clavulanate for treatment of complicated urinary tract infections in adults 
Therapeutic Area Urinary Tract Infections
Principal Investigator Dr. Yoav Golan
Min Age 18 Years
Gender All
Contact Sedina Dzodzomenyo
(617) 636-9094
More Information https://www.clinicaltrials.gov/ct2/show/NCT3357614

Overview

The purpose of this research study is to determine if IV sulopenem followed by oral sulopenem-etzadroxil/probenecid is safe and at least as effective as standard treatment for urinary tract infections 

Study Details

Inclusion Criteria

  • Clinically documented pyelonephritis or complicated urinary tract infection
  • At least two of the following signs or symptoms:
    • rigors, chills, or fever/hypothermia with temperature   > 100.4°F or 38°C, or < 95°F or 35°C
    • flank pain or pelvic pain
    • nausea or vomiting
    • dysuria, urinary frequency, or urinary urgency< />
    • costovertebral angle tenderness on physical examination
  • A mid-stream urine specimen with
    • a machine-read dipstick positive for nitrite AND
    • evidence of pyuria

Exclusion Criteria

  • Receipt of effective antibacterial drug therapy for cUTI for a continuous duration of more than 24 hours in the 72 hours prior to randomization
  • Subjects with an organism isolated from the urine within the last year known to be resistant to ertapenem
  • Severe structural or functional urinary tract abnormality responsible for an intractable infection which in the opinion of the investigator would require > 10 days of therapy or post-treatment prophylaxis

Study Requirements

Approximately 1156 adults with cUTI will be randomized in a 1:1 fashion to receive either IV sulopenem 1000 mg once daily for at least 5 days (5 doses) followed by snlopenem-etzadroxil 500 mg co-administered with oral probenecid 500 mg twice daily to complete 7-10 total days of treatment or ertapenem IV 1000 mg once daily for at least 5 days (5 doses) followed by oral ciprofloxacin 500 mg or amoxicillin-clavulanate 875 mg twice daily to complete 7-10 total days of therapy. Duration of treatment may be extended up to a total duration of 14 days for patients with bacteremia at baseline. Total study participation will last approximately 28 days. At least 16 teaspoons (80 mL) to a maximum of30 teaspoons (150 mL) of blood will be collected over the entire study.