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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
History of Changes

May 29, 2008
August 18, 2011
November 2008
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00690378 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Complicated Urinary Tract Infection
  • Drug: NXL104/ceftazidime
    125mg/500mg TID
  • Drug: Imipenem/Cilastatin
    4 x daily
  • Experimental: 1
    NXL/104 ceftazidime
    Intervention: Drug: NXL104/ceftazidime
  • Active Comparator: 2
    comparator 4 x daily
    Intervention: Drug: Imipenem/Cilastatin
Vazquez JA, González Patzán 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Jordan,   Lebanon
 
NCT00690378
NXL104/2001
No
Carole Sable MD Chief Medical Officer, Novexel Inc
AstraZeneca
Not Provided
Study Director: Carole A Sable, MD Novexel Inc
AstraZeneca
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP