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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

Brief 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.

Condition or disease Intervention/treatment Phase
Complicated Urinary Tract Infection Drug: NXL104/ceftazidime Drug: Imipenem/Cilastatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
NXL/104 ceftazidime
Drug: NXL104/ceftazidime
125mg/500mg TID
Active Comparator: 2
comparator 4 x daily
Drug: Imipenem/Cilastatin
4 x daily



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690378


  Show 59 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Carole A Sable, MD Novexel Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00690378     History of Changes
Other Study ID Numbers: NXL104/2001
C3591013 ( Other Identifier: Alias Study Number )
First Posted: June 4, 2008    Key Record Dates
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases
Imipenem
Ceftazidime
Avibactam
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors