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

NCT00690378

Last updated date
Study Location
Alabama Research Center
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Urinary Tract Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Complicated Urinary Tract InfectionComparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
NCT00690378
  1. Birmingham, Alabama
  2. Dothan, Alabama
  3. Mobile, Alabama
  4. Phoenix, Arizona
  5. Chula Vista, California
  6. Escondido, California
  7. Fountain Valley, California
  8. Long Beach, California
  9. Modesto, California
  10. Oceanside, California
  11. San Jose, California
  12. Sylmar, California
  13. Newark, Delaware
  14. Daytona Beach, Florida
  15. Jacksonville, Florida
  16. Columbus, Georgia
  17. Savannah, Georgia
  18. Paducah, Kentucky
  19. Shreveport, Louisiana
  20. Baltimore, Maryland
  21. Detroit, Michigan
  22. Minneapolis, Minnesota
  23. Saint Louis, Missouri
  24. Butte, Montana
  25. Neptune, New Jersey
  26. Newark, New Jersey
  27. Newark, New Jersey
  28. Albany, New York
  29. Brooklyn, New York
  30. Poughkeepsie, New York
  31. Staten Island, New York
  32. Asheville, North Carolina
  33. Winston-Salem, North Carolina
  34. Akron, Ohio
  35. Columbus, Ohio
  36. Lima, Ohio
  37. Toledo, Ohio
  38. Philadelphia, Pennsylvania
  39. West Reading, Pennsylvania
  40. Azle, Texas
  41. Houston, Texas
  42. Norfolk, Virginia
  43. Amman,
  44. Amman,
  45. Amman,
  46. Irbid,
  47. Beirut,
  48. Beirut,
  49. Beirut,
  50. Beirut,
  51. Beirut,
  52. Byblos,
  53. Chouf,
  54. Dora,
  55. Hazmieh,
  56. Nabatyeh,
  57. Saida,
  58. Saida,
  59. Saida,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Complicated Urinary Tract Infection
Intervention  ICMJE
  • Drug: NXL104/ceftazidime
    125mg/500mg TID
  • Drug: Imipenem/Cilastatin
    4 x daily
Study Arms  ICMJE
  • Experimental: 1
    NXL/104 ceftazidime
    Intervention: Drug: NXL104/ceftazidime
  • Active Comparator: 2
    comparator 4 x daily
    Intervention: Drug: Imipenem/Cilastatin
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2018)
137
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
150
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan,   Lebanon,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690378
Other Study ID Numbers  ICMJE NXL104/2001
C3591013 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Study Director:Carole A Sable, MDNovexel Inc
PRS Account Pfizer
Verification Date March 2018

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