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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Alabama Research Center
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
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

NCT00690378
Pfizer
Completed
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

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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)
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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