Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

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

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

• Verified date: March 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Complicated Urinary Tract Infection
• Infection
• Urinary Tract Infections

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