Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
- Conditions
- Complicated Urinary Tract Infection
- Interventions
- Drug: NXL104/ceftazidimeDrug: Imipenem/Cilastatin
- Registration Number
- NCT00690378
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
- Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens
- ileal loops or vesicoureteral reflux
- complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
- fungal urinary tract infection
- permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
- history hypersensitivity to study medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 NXL104/ceftazidime NXL/104 ceftazidime 2 Imipenem/Cilastatin comparator 4 x daily
- Primary Outcome Measures
Name Time Method Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit 5 to 9 days post-therapy Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
- Secondary Outcome Measures
Name Time Method Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit End of IV therapy (4 to 14 days) Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit 4 to 6 weeks post-therapy Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required
Clinical Outcome in CE Patients at the TOC Visit 5 to 9 days post-therapy Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit 4 to 6 weeks post-therapy Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit End of IV therapy (4 to 14 days) Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome in ME Patients at the LFU Visit 4 to 6 weeks post-therapy Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit End of IV therapy (4 to 14 days) Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit 5 to 9 days post-therapy Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit 4 to 6 weeks post-therapy Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit End of IV therapy (4 to 14 days) Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Microbiological Outcome in ME Patients at the End of IV Therapy Visit End of IV therapy (4 to 14 days) Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit End of IV therapy (4 to 14 days) Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit End of IV therapy (4 to 14 days) Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit 5 to 9 days post-therapy Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit 4 to 6 weeks post-therapy Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit 5 to 9 days post-therapy Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit 5 to 9 days post-therapy Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit 5 to 9 days post-therapy Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit 4 to 6 weeks post-therapy Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Trial Locations
- Locations (58)
Four Rivers Clinical Research Inc
🇺🇸Paducah, Kentucky, United States
Summa Health System Hospitals
🇺🇸Akron, Ohio, United States
Remington-Davis
🇺🇸Columbus, Ohio, United States
Southeast Alabama Medical Center
🇺🇸Dothan, Alabama, United States
Providence Hospital
🇺🇸Mobile, Alabama, United States
Sharp Chula Vista Medical Center
🇺🇸Chula Vista, California, United States
Modesto Clinical Research
🇺🇸Modesto, California, United States
Novellus Research Sites
🇺🇸Long Beach, California, United States
Tri City Medical Center
🇺🇸Oceanside, California, United States
Olive View UCLA Medical Center
🇺🇸Sylmar, California, United States
Louisiana State University Health Services Ctr Shreveport
🇺🇸Shreveport, Louisiana, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
St. James Healthcare
🇺🇸Butte, Montana, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
Brookdale University Hospital
🇺🇸Brooklyn, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Regional Infectious Disease-Infusion Center
🇺🇸Lima, Ohio, United States
St Vincent's Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Thomas Jefferson Univ Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸West Reading, Pennsylvania, United States
Harris Methodist
🇺🇸Azle, Texas, United States
Sentara Norfold General Hospital
🇺🇸Norfolk, Virginia, United States
Al-Essra hospital
🇯🇴Amman, Jordan
Jordan University Hospital
🇯🇴Amman, Jordan
Clinique due Levant Hospital
🇱🇧Beirut, Lebanon
St. Joseph Hospital
🇱🇧Dora, Lebanon
Hammoud Hospital University Medical Center
🇱🇧Saida, Lebanon
University Hospital UMDNJ
🇺🇸Newark, New Jersey, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
Century Clinical Research, Inc
🇺🇸Daytona Beach, Florida, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
R. Adams Cowley Shock Trauma Center
🇺🇸Baltimore, Maryland, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Al-Islami Hospital
🇯🇴Amman, Jordan
King Abdullah University Hospital
🇯🇴Irbid, Jordan
Dr. Rizk Clinic
🇱🇧Beirut, Lebanon
Sahel General Hospital
🇱🇧Beirut, Lebanon
Mount Lebanon Hospital
🇱🇧Hazmieh, Lebanon
Makassed General Hospital
🇱🇧Beirut, Lebanon
Nabatyeh Governmental Hospital
🇱🇧Nabatyeh, Lebanon
Rafik Hariri University Hospital
🇱🇧Beirut, Lebanon
Notre Dame Des Secours Hospital
🇱🇧Byblos, Lebanon
Ain Wazein Hospital
🇱🇧Chouf, Lebanon
Labib Medical Center
🇱🇧Saida, Lebanon
Saida Governmental Hospital
🇱🇧Saida, Lebanon
St. Joseph's/Candler Health System
🇺🇸Savannah, Georgia, United States
Southeast Regional Research Group
🇺🇸Columbus, Georgia, United States
Synergy Clinical Research Center
🇺🇸Escondido, California, United States
EStudy Site
🇺🇸San Jose, California, United States
University of Texas MD Anderson
🇺🇸Houston, Texas, United States
North Memorial Medical Center
🇺🇸Minneapolis, Minnesota, United States
Arizona Pulmonary Specialists LTD
🇺🇸Phoenix, Arizona, United States
Alabama Research Center
🇺🇸Birmingham, Alabama, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Clinical Trials of America Inc.
🇺🇸Winston-Salem, North Carolina, United States