Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections
NCT ID: NCT01281462
Last Updated: 2014-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
217 participants
INTERVENTIONAL
2010-12-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ceftaroline fosamil and NXL104 (q8h)
Ceftaroline fosamil and NXL104 (q8h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
Placebo
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.
Ceftaroline fosamil and NXL104 (q12h)
Ceftaroline fosamil and NXL104 (q12h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
Placebo
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.
Doripenem
Doripenem
500 mg doripenem IV q8h;
Placebo
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.
Interventions
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Ceftaroline fosamil and NXL104 (q8h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
Ceftaroline fosamil and NXL104 (q12h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
Doripenem
500 mg doripenem IV q8h;
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Investigational Site
La Mesa, California, United States
Investigational Site
San Diego, California, United States
Investigational Site
Pensacola, Florida, United States
Investigational Site
Baltimore, Maryland, United States
Investigational Site
Detroit, Michigan, United States
Investigational Site
Plovdiv, , Bulgaria
Investigational Site
Rousse, , Bulgaria
Investigational Site
Sofia, , Bulgaria
Investigational Site
Sofia, , Bulgaria
Investigational Site
Sofia, , Bulgaria
Investigational Site
Varna, , Bulgaria
Investigational Site
Berlin, , Germany
Investigational Site
Freiburg im Breisgau, , Germany
Investigational Site
Giessen, , Germany
Investigational Site
Kassel, , Germany
Investigational Site
Minden, , Germany
Investigational Site
Müllheim, , Germany
Investigational Site
Paderborn, , Germany
Investigational Site
Planegg, , Germany
Investigational Site
Beirut, , Lebanon
Investigational Site
Bialystok, , Poland
Investigational Site
Bielsko-Biala, , Poland
Investigational Site
Częstochowa, , Poland
Investigational Site
Katowice, , Poland
Investigational Site
Katowice, , Poland
Investigational Site
Lodz, , Poland
Investigational Site
Tychy, , Poland
Investigational Site
Warsaw, , Poland
Investigational Site
Wołomin, , Poland
Investigational Site
Wroclaw, , Poland
Investigational Site
Zamość, , Poland
Investigational Site
Moscow, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Moscow, , Russia
Investigational Site
Rostov-on-Don, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Saint Petersburg, , Russia
Investigational Site
Smolensk, , Russia
Investigational Site
Diyarbakır, , Turkey (Türkiye)
Investigational Site
Eskişehir, , Turkey (Türkiye)
Investigational Site
Izmir, , Turkey (Türkiye)
Investigational Site
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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CXL-MD-02
Identifier Type: -
Identifier Source: org_study_id
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