Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00690378

Purpose

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.

Condition	Intervention	Phase
Complicated Urinary Tract Infection	Drug: NXL104/ceftazidime Drug: Imipenem/Cilastatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Imipenem Ceftazidime Cilastatin sodium Cilastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Estimate the by-patient microbiological response of NXL104/ceftazidime in the treatment of adult patients with complicated urinary tract infections (cUTI) [ Time Frame: 5 to 9 days post-therapy ] [ Designated as safety issue: No ]
Evaluate the safety and tolerability profile [ Time Frame: Treatment plus 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Estimate the clinical outcome of NXL104/ceftazidime [ Time Frame: End of IV therapy, Test of Cure visit 5 to 9 days post-therapy and late follow-up visit ] [ Designated as safety issue: No ]
Estimate the by-pathogen microbiological response [ Time Frame: End of IV therapy, the Test of Cure visit 5 to 9 days post-therapy and at the late follow-up visit ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	November 2008
Study Completion Date:	July 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 NXL/104 ceftazidime	Drug: NXL104/ceftazidime 125mg/500mg TID
Active Comparator: 2 comparator 4 x daily	Drug: Imipenem/Cilastatin 4 x daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690378

Show 59 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Carole A Sable, MD

Novexel Inc

More Information

No publications provided

Responsible Party:	Carole Sable MD Chief Medical Officer, Novexel Inc
ClinicalTrials.gov Identifier:	NCT00690378 History of Changes
Other Study ID Numbers:	NXL104/2001
Study First Received:	May 29, 2008
Last Updated:	August 18, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Tract Infections
Infection
Urologic Diseases
Ceftazidime
Imipenem
Cilastatin
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012