Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections

This study has been completed.

First Received: September 11, 2008 Last Updated: December 1, 2009 History of Changes

Sponsor:	Novexel Inc
Information provided by:	Novexel Inc
ClinicalTrials.gov Identifier:	NCT00752219

Purpose

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

Condition	Intervention	Phase
Complicated Intra-Abdominal Infections	Drug: ceftazidime/NXL104 + metronidazole Drug: meropenem	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults

Resource links provided by NLM:

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Ceftazidime Meropenem Metronidazole

U.S. FDA Resources

Further study details as provided by Novexel Inc:

Primary Outcome Measures:

To estimate the efficacy of NXL104/ceftazidime with respect to the clinical response in baseline microbiologically evaluable patients with cIAI at the Test of Cure (TOC) visit [ Time Frame: 2 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

evaluate the safety and tolerability profile of NXL104/ceftazidime in the treatment of cIAI in adults [ Time Frame: Treatment plus 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	March 2009
Study Completion Date:	December 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ceftazidime/NXL104 + metronidazole TID	Drug: ceftazidime/NXL104 + metronidazole IV TID
2: Active Comparator meropenem TID	Drug: meropenem IV TID

Eligibility

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

Criteria

Inclusion Criteria:

complicated intra-abdominal infections

Exclusion Criteria:

infections limited to hollow viscus
ischemic bowel disease without perforation
acute suppurative cholangitis
acute necrotizing pancreatitis
pts to undergo stated abdominal repair, open abdomen technique or marsupialization
Apache II >25

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752219

Show 45 Study Locations

Sponsors and Collaborators

Novexel Inc

More Information

No publications provided

Responsible Party:	Novexel Inc ( Carole Sable MD Chief Medical Officer )
Study ID Numbers:	NXL104/2002
Study First Received:	September 11, 2008
Last Updated:	December 1, 2009
ClinicalTrials.gov Identifier:	NCT00752219 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Communicable Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Physiological Effects of Drugs
Infection
Pharmacologic Actions

Ceftazidime
Anti-Bacterial Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Meropenem
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010