Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections
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
1 other identifier
interventional
217
7 countries
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 13, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFebruary 3, 2014
January 1, 2014
1.2 years
January 13, 2011
January 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)
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)
5 to 11 days after last dose of study drug
Evaluate safety
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.
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 (1)
Clinical response in CE at Test of Cure
5 to 11 days after last dose of study drug
Study Arms (3)
Ceftaroline fosamil and NXL104 (q8h)
EXPERIMENTALCeftaroline fosamil and NXL104 (q12h)
EXPERIMENTALDoripenem
ACTIVE COMPARATORInterventions
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Investigational Site
La Mesa, California, 91942, United States
Investigational Site
San Diego, California, 92120, United States
Investigational Site
Pensacola, Florida, 32504, United States
Investigational Site
Baltimore, Maryland, 21287, United States
Investigational Site
Detroit, Michigan, 48202, United States
Investigational Site
Plovdiv, 4002, Bulgaria
Investigational Site
Rousse, 7002, Bulgaria
Investigational Site
Sofia, 1407, Bulgaria
Investigational Site
Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Varna, 9002, Bulgaria
Investigational Site
Berlin, 10117, Germany
Investigational Site
Freiburg im Breisgau, 79106, Germany
Investigational Site
Giessen, 35385, Germany
Investigational Site
Kassel, 34125, Germany
Investigational Site
Minden, 32429, Germany
Investigational Site
Müllheim, 79379, Germany
Investigational Site
Paderborn, 33098, Germany
Investigational Site
Planegg, 82152, Germany
Investigational Site
Beirut, Lebanon
Investigational Site
Bialystok, 15-950, Poland
Investigational Site
Bielsko-Biala, 43-316, Poland
Investigational Site
Częstochowa, 42-200, Poland
Investigational Site
Katowice, 40-073, Poland
Investigational Site
Katowice, 40-752, Poland
Investigational Site
Lodz, 90-153, Poland
Investigational Site
Tychy, 43-100, Poland
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Warsaw, 03-401, Poland
Investigational Site
Wołomin, 05-200, Poland
Investigational Site
Wroclaw, 50-349, Poland
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Zamość, 22-400, Poland
Investigational Site
Moscow, 105077, Russia
Investigational Site
Moscow, 105425, Russia
Investigational Site
Moscow, 111123, Russia
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Moscow, 119049, Russia
Investigational Site
Moscow, 119992-119435, Russia
Investigational Site
Rostov-on-Don, 344022, Russia
Investigational Site
Saint Petersburg, 193312, Russia
Investigational Site
Saint Petersburg, 194044, Russia
Investigational Site
Saint Petersburg, 194291, Russia
Investigational Site
Saint Petersburg, 194354, Russia
Investigational Site
Saint Petersburg, 195067, Russia
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Saint Petersburg, 196247, Russia
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Saint Petersburg, 198205, Russia
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Saint Petersburg, 199178, Russia
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Smolensk, 214018, Russia
Investigational Site
Diyarbakır, 21280, Turkey (Türkiye)
Investigational Site
Eskişehir, 26480, Turkey (Türkiye)
Investigational Site
Izmir, 35040, Turkey (Türkiye)
Investigational Site
Izmir, 35340, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Forest Laboratories
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2011
First Posted
January 24, 2011
Study Start
December 1, 2010
Primary Completion
March 1, 2012
Study Completion
July 1, 2012
Last Updated
February 3, 2014
Record last verified: 2014-01