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

Tracking Information

First Received Date ^ICMJE

May 29, 2008

Last Updated Date

June 11, 2009

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Evaluate the safety and tolerability profile [ Time Frame: Treatment plus 14 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00690378 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Complicated Urinary Tract Infection

Intervention ^ICMJE

Drug: NXL104/ceftazidime
Drug: Imipenem/Cilastatin

Study Arms / Comparison Groups

Experimental: NXL/104 ceftazidime
Active Comparator: comparator 4 x daily

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

December 2009

Estimated Primary Completion Date

October 2009 (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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Carole A Sable, MD

484-362-2663

carole.sable@novexel.com

Location Countries ^ICMJE

United States, Jordan, Lebanon

Administrative Information

NCT ID ^ICMJE

NCT00690378

Responsible Party

Carole Sable MD Chief Medical Officer, Novexel Inc

Study ID Numbers ^ICMJE

NXL104/2001

Study Sponsor ^ICMJE

Novexel Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Carole A Sable, MD

Novexel Inc

Information Provided By

Novexel Inc

Verification Date

June 2009

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