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

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ClinicalTrials.gov Identifier: NCT00690378
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

May 29, 2008
June 4, 2008
September 1, 2017
May 25, 2018
May 25, 2018
November 2008
June 2010   (Final data collection date for primary outcome measure)
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit [ Time Frame: 5 to 9 days post-therapy ]
Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • 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 ]
  • Evaluate the safety and tolerability profile [ Time Frame: Treatment plus 14 days ]
Complete list of historical versions of study NCT00690378 on ClinicalTrials.gov Archive Site
  • Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit [ Time Frame: End of IV therapy (4 to 14 days) ]
    Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
  • Clinical Outcome in CE Patients at the TOC Visit [ Time Frame: 5 to 9 days post-therapy ]
    Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
  • Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit [ Time Frame: 4 to 6 weeks post-therapy ]
    Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required
  • Microbiological Outcome in ME Patients at the End of IV Therapy Visit [ Time Frame: End of IV therapy (4 to 14 days) ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome in ME Patients at the LFU Visit [ Time Frame: 4 to 6 weeks post-therapy ]
    Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit [ Time Frame: End of IV therapy (4 to 14 days) ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit [ Time Frame: End of IV therapy (4 to 14 days) ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit [ Time Frame: End of IV therapy (4 to 14 days) ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit [ Time Frame: End of IV therapy (4 to 14 days) ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit [ Time Frame: End of IV therapy (4 to 14 days) ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit [ Time Frame: 5 to 9 days post-therapy ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit [ Time Frame: 5 to 9 days post-therapy ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit [ Time Frame: 5 to 9 days post-therapy ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit [ Time Frame: 5 to 9 days post-therapy ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit [ Time Frame: 5 to 9 days post-therapy ]
    Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit [ Time Frame: 4 to 6 weeks post-therapy ]
    Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit [ Time Frame: 4 to 6 weeks post-therapy ]
    Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit [ Time Frame: 4 to 6 weeks post-therapy ]
    Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
  • Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit [ Time Frame: 4 to 6 weeks post-therapy ]
    Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
  • 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 ]
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Single (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
137
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Jordan,   Lebanon,   United States
 
 
NCT00690378
NXL104/2001
C3591013 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Carole A Sable, MD Novexel Inc
Pfizer
March 2018

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