A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults

This study has been completed.

First Received: June 1, 2007 Last Updated: October 8, 2007 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00481702

Purpose

A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.

Condition	Intervention	Phase
Intra-Abdominal Infection	Drug: Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks Drug: MK0826, /Duration of Treatment : 8 Weeks Drug: Comparator: metronidazole / Duration of Treatment: 8 Weeks	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults

Resource links provided by NLM:

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Ceftriaxone Ceftriaxone Sodium L 749345 Ertapenem Metronidazole

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection [ Time Frame: 2 weeks after treatment ]

Secondary Outcome Measures:

That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection [ Time Frame: 4 weeks after treatment ]

Estimated Enrollment:	300
Study Start Date:	January 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients age 18 or older
Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

Exclusion Criteria:

Patient has another infection, other than abdominal
Female patient is pregnant or planning to become pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481702

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Navarro NS Jr, Campos MI, Alvarado R, Quintero N, Branicki FJ, Wei J, Shivaprakash M, Vrijens F, Giezek H, Chan CY, DiNubile MJ, Oasis II Study Team. Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections. Int J Surg. 2005;3(1):25-34.

Study ID Numbers:	2007_558
Study First Received:	June 1, 2007
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00481702 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Metronidazole
Communicable Diseases
Antiparasitic Agents
Antiprotozoal Agents

Radiation-Sensitizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Ceftriaxone
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009