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

Sponsor:	Novexel Inc
Information provided by:	Novexel Inc
ClinicalTrials.gov Identifier:	NCT00690378

Purpose

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	Intervention	Phase
Complicated Urinary Tract Infection	Drug: NXL104/ceftazidime Drug: Imipenem/Cilastatin	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Imipenem Ceftazidime Cilastatin sodium Cilastatin

U.S. FDA Resources

Further study details as provided by Novexel Inc:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	150
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental NXL/104 ceftazidime	Drug: NXL104/ceftazidime 125mg/500mg TID
2: Active Comparator comparator 4 x daily	Drug: Imipenem/Cilastatin 4 x daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690378

Contacts

Contact: Carole A Sable, MD

484-362-2663

carole.sable@novexel.com

Show 59 Study Locations

Sponsors and Collaborators

Novexel Inc

Investigators

Study Director:

Carole A Sable, MD

Novexel Inc

More Information

No publications provided

Responsible Party:	Novexel Inc ( Carole Sable MD Chief Medical Officer )
Study ID Numbers:	NXL104/2001
Study First Received:	May 29, 2008
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00690378 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Urinary Tract Infections
Enzyme Inhibitors
Infection
Pharmacologic Actions

Protease Inhibitors
Ceftazidime
Anti-Bacterial Agents
Urologic Diseases
Cilastatin
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2009