Complicated Urinary Tract Infection Clinical Trial
Official title:
Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study Estimate Safety, Tolerability, Efficacy of NXL104/Ceftazidime vs. Comparator Followed Appropriate Oral Therapy Treatment Complicated UTI Hosp Adults
Verified date | March 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 137 |
Est. completion date | July 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Jordan | Al-Essra hospital | Amman | |
Jordan | Al-Islami Hospital | Amman | |
Jordan | Jordan University Hospital | Amman | |
Jordan | King Abdullah University Hospital | Irbid | |
Lebanon | Clinique due Levant Hospital | Beirut | |
Lebanon | Dr. Rizk Clinic | Beirut | |
Lebanon | Makassed General Hospital | Beirut | |
Lebanon | Rafik Hariri University Hospital | Beirut | |
Lebanon | Sahel General Hospital | Beirut | |
Lebanon | Notre Dame Des Secours Hospital | Byblos | |
Lebanon | Ain Wazein Hospital | Chouf | |
Lebanon | St. Joseph Hospital | Dora | |
Lebanon | Mount Lebanon Hospital | Hazmieh | |
Lebanon | Nabatyeh Governmental Hospital | Nabatyeh | |
Lebanon | Hammoud Hospital University Medical Center | Saida | |
Lebanon | Labib Medical Center | Saida | |
Lebanon | Saida Governmental Hospital | Saida | |
United States | Summa Health System Hospitals | Akron | Ohio |
United States | Albany Medical Center | Albany | New York |
United States | Mission Hospital | Asheville | North Carolina |
United States | Harris Methodist | Azle | Texas |
United States | R. Adams Cowley Shock Trauma Center | Baltimore | Maryland |
United States | Alabama Research Center | Birmingham | Alabama |
United States | Brookdale University Hospital | Brooklyn | New York |
United States | St. James Healthcare | Butte | Montana |
United States | Sharp Chula Vista Medical Center | Chula Vista | California |
United States | Remington-Davis | Columbus | Ohio |
United States | Southeast Regional Research Group | Columbus | Georgia |
United States | Century Clinical Research, Inc | Daytona Beach | Florida |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Southeast Alabama Medical Center | Dothan | Alabama |
United States | Synergy Clinical Research Center | Escondido | California |
United States | Novellus Research Sites | Fountain Valley | California |
United States | University of Texas MD Anderson | Houston | Texas |
United States | University of Florida | Jacksonville | Florida |
United States | Regional Infectious Disease-Infusion Center | Lima | Ohio |
United States | Novellus Research Sites | Long Beach | California |
United States | North Memorial Medical Center | Minneapolis | Minnesota |
United States | Providence Hospital | Mobile | Alabama |
United States | Modesto Clinical Research | Modesto | California |
United States | Jersey Shore University Medical Center | Neptune | New Jersey |
United States | Christiana Care Health Services | Newark | Delaware |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | University Hospital UMDNJ | Newark | New Jersey |
United States | Sentara Norfold General Hospital | Norfolk | Virginia |
United States | Tri City Medical Center | Oceanside | California |
United States | Four Rivers Clinical Research Inc | Paducah | Kentucky |
United States | Thomas Jefferson Univ Hospital | Philadelphia | Pennsylvania |
United States | Arizona Pulmonary Specialists LTD | Phoenix | Arizona |
United States | Vassar Brothers Medical Center | Poughkeepsie | New York |
United States | Saint Louis University Hospital | Saint Louis | Missouri |
United States | EStudy Site | San Jose | California |
United States | St. Joseph's/Candler Health System | Savannah | Georgia |
United States | Louisiana State University Health Services Ctr Shreveport | Shreveport | Louisiana |
United States | Staten Island University Hospital | Staten Island | New York |
United States | Olive View UCLA Medical Center | Sylmar | California |
United States | St Vincent's Mercy Medical Center | Toledo | Ohio |
United States | Reading Hospital and Medical Center | West Reading | Pennsylvania |
United States | Clinical Trials of America Inc. | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Jordan, Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy | |
Secondary | Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit | Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required | End of IV therapy (4 to 14 days) | |
Secondary | Clinical Outcome in CE Patients at the TOC Visit | Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required | 5 to 9 days post-therapy | |
Secondary | Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit | Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required | 4 to 6 weeks post-therapy | |
Secondary | Microbiological Outcome in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) | |
Secondary | Microbiological Outcome in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) | |
Secondary | Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) | |
Secondary | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) | |
Secondary | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) | |
Secondary | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | End of IV therapy (4 to 14 days) | |
Secondary | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit | Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL | 5 to 9 days post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy | |
Secondary | Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit | Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL | 4 to 6 weeks post-therapy |
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