Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
Information source: Novexel Inc
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complicated Urinary Tract Infection
Intervention: NXL104/ceftazidime (Drug); Imipenem/Cilastatin (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Novexel Inc Official(s) and/or principal investigator(s):
Carole A Sable, MD, Study Director, Affiliation: Novexel Inc
Overall contact:
Carole A Sable, MD, Phone: 484-362-2663, Email: carole.sable@novexel.com
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.
Clinical Details
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 design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Estimate the by-patient microbiological response of NXL104/ceftazidime in the treatment of adult patients with complicated urinary tract infections (cUTI)Evaluate the safety and tolerability profile
Secondary outcome: Estimate the clinical outcome of NXL104/ceftazidimeEstimate the by-pathogen microbiological response
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Carole A Sable, MD, Phone: 484-362-2663, Email: carole.sable@novexel.com
Precision Clinical Research, Mobile, Alabama 36695, United States
Alabama Research Center, Birmingham, Alabama 35209, United States
eStudySite, Oceanside, California 92056, United States
Olive View UCLA Medical Center, Sylmar, California 91342, United States
Christina Care Health Services, Newark, Delaware 19718, United States
Hudson Valley Urology, P.C., Poughkeepsie, New York 12601, United States
Upstate Infectious Disease Associates, LLP, Albany, New York 12208, United States
Remington-Davis, Inc, Columbus, Ohio 43215, United States
Additional Information
Starting date: June 2008
Ending date: May 2009
Last updated: June 3, 2008
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