Clinical trial NCT00690378: Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complicated Urinary Tract Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
timeFrame: 5 to 9 days post-therapy
Secondary outcomes:
measure: Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
timeFrame: End of IV therapy (4 to 14 days)
measure: Clinical Outcome in CE Patients at the TOC Visit
timeFrame: 5 to 9 days post-therapy
measure: Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
timeFrame: 4 to 6 weeks post-therapy
measure: Microbiological Outcome in ME Patients at the End of IV Therapy Visit
timeFrame: End of IV therapy (4 to 14 days)
measure: Microbiological Outcome in ME Patients at the LFU Visit
timeFrame: 4 to 6 weeks post-therapy
measure: Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit
timeFrame: End of IV therapy (4 to 14 days)
measure: Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit
timeFrame: End of IV therapy (4 to 14 days)
measure: Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit
timeFrame: End of IV therapy (4 to 14 days)
measure: Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit
timeFrame: End of IV therapy (4 to 14 days)
measure: Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit
timeFrame: End of IV therapy (4 to 14 days)
measure: Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit
timeFrame: 5 to 9 days post-therapy
measure: Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit
timeFrame: 5 to 9 days post-therapy
measure: Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit
timeFrame: 5 to 9 days post-therapy
measure: Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit
timeFrame: 5 to 9 days post-therapy
measure: Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit
timeFrame: 5 to 9 days post-therapy
measure: Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit
timeFrame: 4 to 6 weeks post-therapy
measure: Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit
timeFrame: 4 to 6 weeks post-therapy
measure: Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit
timeFrame: 4 to 6 weeks post-therapy
measure: Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit
timeFrame: 4 to 6 weeks post-therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Research Center
state: Alabama
city: Dothan
country: United States
facility: Southeast Alabama Medical Center
state: Alabama
city: Mobile
country: United States
facility: Providence Hospital
state: Alabama
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists LTD
state: Arizona
city: Chula Vista
country: United States
facility: Sharp Chula Vista Medical Center
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center
state: California
city: Fountain Valley
country: United States
facility: Novellus Research Sites
state: California
city: Long Beach
country: United States
facility: Novellus Research Sites
state: California
city: Modesto
country: United States
facility: Modesto Clinical Research
state: California
city: Oceanside
country: United States
facility: Tri City Medical Center
state: California
city: San Jose
country: United States
facility: EStudy Site
state: California
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Daytona Beach
country: United States
facility: Century Clinical Research, Inc
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Savannah
country: United States
facility: St. Joseph's/Candler Health System
state: Georgia
city: Paducah
country: United States
facility: Four Rivers Clinical Research Inc
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University Health Services Ctr Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: R. Adams Cowley Shock Trauma Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Butte
country: United States
facility: St. James Healthcare
state: Montana
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Newark
country: United States
facility: University Hospital UMDNJ
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Brooklyn
country: United States
facility: Brookdale University Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America Inc.
state: North Carolina
city: Akron
country: United States
facility: Summa Health System Hospitals
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis
state: Ohio
city: Lima
country: United States
facility: Regional Infectious Disease-Infusion Center
state: Ohio
city: Toledo
country: United States
facility: St Vincent's Mercy Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson Univ Hospital
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Azle
country: United States
facility: Harris Methodist
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfold General Hospital
state: Virginia
city: Amman
country: Jordan
facility: Al-Essra hospital
city: Amman
country: Jordan
facility: Al-Islami Hospital
city: Amman
country: Jordan
facility: Jordan University Hospital
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
city: Beirut
country: Lebanon
facility: Clinique due Levant Hospital
city: Beirut
country: Lebanon
facility: Dr. Rizk Clinic
city: Beirut
country: Lebanon
facility: Makassed General Hospital
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Beirut
country: Lebanon
facility: Sahel General Hospital
city: Byblos
country: Lebanon
facility: Notre Dame Des Secours Hospital
city: Chouf
country: Lebanon
facility: Ain Wazein Hospital
city: Dora
country: Lebanon
facility: St. Joseph Hospital
city: Hazmieh
country: Lebanon
facility: Mount Lebanon Hospital
city: Nabatyeh
country: Lebanon
facility: Nabatyeh Governmental Hospital
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Saida
country: Lebanon
facility: Labib Medical Center
city: Saida
country: Lebanon
facility: Saida Governmental Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: Novexel Inc
name: Carole A Sable, MD
role: STUDY_DIRECTOR
References:
citation: Vazquez JA, Gonzalez Patzan LD, Stricklin D, Duttaroy DD, Kreidly Z, Lipka J, Sable C. Efficacy and safety of ceftazidime-avibactam versus imipenem-cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study. Curr Med Res Opin. 2012 Dec;28(12):1921-31. doi: 10.1185/03007995.2012.748653. Epub 2012 Nov 21.