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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00690378
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : August 19, 2011
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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 : 150 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. Estimate the by-patient microbiological response of NXL104/ceftazidime in the treatment of adult patients with complicated urinary tract infections (cUTI) [ Time Frame: 5 to 9 days post-therapy ]
  2. Evaluate the safety and tolerability profile [ Time Frame: Treatment plus 14 days ]

Secondary Outcome Measures :
  1. Estimate the clinical outcome of NXL104/ceftazidime [ Time Frame: End of IV therapy, Test of Cure visit 5 to 9 days post-therapy and late follow-up visit ]
  2. Estimate the by-pathogen microbiological response [ Time Frame: End of IV therapy, the Test of Cure visit 5 to 9 days post-therapy and at the late follow-up visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00690378

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Sponsors and Collaborators
Study Director: Carole A Sable, MD Novexel Inc

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carole Sable MD Chief Medical Officer, Novexel Inc Identifier: NCT00690378     History of Changes
Other Study ID Numbers: NXL104/2001
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: August 2011

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