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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690378
First received: May 29, 2008
Last updated: August 18, 2011
Last verified: August 2011
  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 2

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:


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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 17, 2014