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Completed

NCT Number: NCT00690378

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

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.

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Key information

Conditions

Complicated Urinary Tract Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-Essra hospital, Amman, Jordan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NXL104/ceftazidime

Drug

125mg/500mg TID

imipenem/cilastatin

Drug

4 x daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 4, 2008
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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