Urinary Tract Infections
Conditions
Keywords
complicated Urinary Tract Infection, Acute Pyelonephritis
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.
Interventions
DRUGCeftaroline fosamil and NXL104 (q12h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
DRUGDoripenem
500 mg doripenem IV q8h;
DRUGCeftaroline fosamil and NXL104 (q8h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
DRUGPlacebo
On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical response in CE at Test of Cure | 5 to 11 days after last dose of study drug | The number and percentage of subjects in each treatment group classified as clinical cure Clinically Evaluable (CE) Population at TOC |
Countries
Bulgaria, Germany, Lebanon, Poland, Russia, Turkey (Türkiye), United States
Outcome results
None listed