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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00690378
Other study ID # NXL104/2001
Secondary ID C3591013
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2008
Est. completion date July 2010

Study information

Verified date March 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NXL104/ceftazidime
125mg/500mg TID
Imipenem/Cilastatin
4 x daily

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Jordan,  Lebanon, 

Outcome

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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