Clinical trial NCT01281462: Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Infections
Keywords: complicated Urinary Tract Infection
Acute Pyelonephritis
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Renal transplantation
* Life expectancy less than 3 months
* Evidence of significant hepatic, hematological, or immunologic disease or dysfunction
* Past or current history of epilepsy or seizure disorder
* Women who are pregnant or nursing

Primary outcomes:
measure: Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)
timeFrame: 5 to 11 days after last dose of study drug
measure: Evaluate safety
timeFrame: 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)
Secondary outcomes:
measure: Clinical response in CE at Test of Cure
timeFrame: 5 to 11 days after last dose of study drug
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Pensacola
country: United States
facility: Investigational Site
state: Florida
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Detroit
country: United States
facility: Investigational Site
state: Michigan
city: Plovdiv
country: Bulgaria
facility: Investigational Site
city: Ruse
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Sofia
country: Bulgaria
facility: Investigational Site
city: Varna
country: Bulgaria
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Freiburg
country: Germany
facility: Investigational Site
city: Gießen
country: Germany
facility: Investigational Site
city: Kassel
country: Germany
facility: Investigational Site
city: Minden
country: Germany
facility: Investigational Site
city: Muellheim
country: Germany
facility: Investigational Site
city: Paderborn
country: Germany
facility: Investigational Site
city: Planegg
country: Germany
facility: Investigational Site
city: Beirut
country: Lebanon
facility: Investigational Site
city: Bialystok
country: Poland
facility: Investigational Site
city: Bielsko-Biala
country: Poland
facility: Investigational Site
city: Częstochowa
country: Poland
facility: Investigational Site
city: Katowice
country: Poland
facility: Investigational Site
city: Katowice
country: Poland
facility: Investigational Site
city: Lodz
country: Poland
facility: Investigational Site
city: Tychy
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Wolomin
country: Poland
facility: Investigational Site
city: Wrocław
country: Poland
facility: Investigational Site
city: Zamosc
country: Poland
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Investigational Site
city: Smolensk
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: Diyarbakir
country: Turkey
facility: Investigational Site
city: Eskisehir
country: Turkey
facility: Investigational Site
city: Izmir
country: Turkey
facility: Investigational Site
city: Izmir
country: Turkey
facility: Investigational Site
Study officials:
affiliation: Forest Laboratories
name: Medical Monitor
role: STUDY_DIRECTOR
References: