A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection
Overview
- Phase
- Phase 2
- Intervention
- Ceftaroline fosamil and NXL104 (q8h)
- Conditions
- Urinary Tract Infections
- Sponsor
- Forest Laboratories
- Enrollment
- 217
- Locations
- 1
- Primary Endpoint
- Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet the following inclusion criteria:
- •Have pyuria (white blood cells in the urine)
- •Clinical signs and/or symptoms of cUTI (including acute pyelonephritis)
- •Have a pretreatment baseline urine culture specimen
- •The subject's infection would require initial treatment with IV antibiotics
- •The subject must require initial hospitalization to manage the cUTI by the standard of care.
Exclusion Criteria
- •Subjects must NOT meet any of the following exclusion criteria:
- •History of any hypersensitivity or allergic reaction to any β-lactam (eg, cephalosporins, penicillins, carbapenems)
- •Confirmed fungal urinary tract infection
- •Intractable UTI anticipated to require more than 10 days of study drug therapy
- •Complete, permanent obstruction of the urinary tract\\
- •Permanent indwelling bladder catheter or instrumentation (including nephrostomy) or current urinary catheter that will not be removed during IV study drug administration
- •Suspected or confirmed perinephric or intrarenal abscess
- •Suspected or confirmed prostatitis
- •Ileal loops or vesico-ureteral reflux
- •Impairment of renal function including a calculated CrCl of \< 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria
Arms & Interventions
Ceftaroline fosamil and NXL104 (q8h)
Intervention: Ceftaroline fosamil and NXL104 (q8h)
Ceftaroline fosamil and NXL104 (q8h)
Intervention: Placebo
Ceftaroline fosamil and NXL104 (q12h)
Intervention: Ceftaroline fosamil and NXL104 (q12h)
Ceftaroline fosamil and NXL104 (q12h)
Intervention: Placebo
Doripenem
Intervention: Doripenem
Doripenem
Intervention: Placebo
Outcomes
Primary Outcomes
Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)
Time Frame: 5 to 11 days after last dose of study drug
The number and percentage of subjects in each treatment group recorded as having a favorable microbiological response in the ME Population at Test-of-Cure (TOC)
Evaluate safety
Time Frame: from administration of first dose of study drug to the Late -Follow -Up (LFU) visit (28 to 42 days after administration of the last dose of study drug)
Evaluate the safety of coadministered IV ceftaroline fosamil and NXL104 in subjects with cUTI. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology and coagulation studies, comprehensive metabolic panel, and urinalysis), vital signs, ECGs, and physical examinations will be provided for each treatment group.
Secondary Outcomes
- Clinical response in CE at Test of Cure(5 to 11 days after last dose of study drug)