Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infect… (NCT03687255) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections
United States1,043 participantsStarted 2018-09-24
Plain-language summary
Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female patients \>18 years of age at the time of signing of informed consent;
✓. Expectation that the patient's cUTI or AP will require hospitalisation and initial treatment with at least 7 days of intravenous (i.v.) antibiotics;
✓. Female patients who are no longer of childbearing potential
✓. Female patients of childbearing potential must have a negative urine and/or serum pregnancy test (serum β-human chorionic gonadotropin) within 1 day prior to study entry;
✓. Male patients, female patients receiving hormone replacement therapy (HRT), and female patients of childbearing potential must agree to use highly effective contraception methods
✓. Pyuria, defined as: a. White blood cell count \>10 cells/mm3 in unspun urine or ≥10 cells/high power field in spun urine sediment; or b. Urinalysis/dipstick analysis positive for leukocyte esterase;
✓. Clinical signs and/or symptoms of cUTI or AP
✓. Have a baseline urine culture specimen obtained within 48 hours prior to randomization
Exclusion criteria
✕. Known urine culture with Gram-positive primary pathogen at ≥105 colony-forming units (CFU)/mL (not contaminant) or suspected Gram-positive pathogen by Gram staining (Note: Gram staining is optional);
✕. History of significant hypersensitivity or allergic reaction to cefepime, piperacillin/tazobactam, any of the excipients used in the respective formulations, any beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams), or any beta-lactamase inhibitors (e.g., tazobactam, sulbactam, or clavulanic acid);
What they're measuring
1
Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC)
Timeframe: 7 days after EOT [±2 days] for patients receiving 7 days of treatment and 19 days after randomization [±2 days] for patients receiving more than 7 days of treatment.
✕. In the opinion of the Investigator, the patient is considered unlikely to survive the approximately 6-week study period;
✕. Weight \>180 kg;
✕. Concurrent infection that would interfere with evaluation of response to the study antibiotics;
✕. Need for or receipt of concomitant systemic antimicrobial agents after signing of informed consent, in addition to those designated in the study-treatment groups, with the exception of a single oral dose of any antifungal treatment for vaginal candidiasis;
✕. Receipt of potentially effective systemic antibacterial therapy for a continuous duration of \> 24 hours during the previous 72 hours before the study-qualifying baseline urine is obtained;
✕. Complicated urinary tract infection (UTI) known at study entry to be caused by pathogens resistant to the study antibiotics;