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

Tracking Information

First Received Date ^ICMJE

June 1, 2007

Last Updated Date

October 8, 2007

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00481702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Intra-Abdominal Infection

Intervention ^ICMJE

Drug: Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks
Drug: MK0826, /Duration of Treatment : 8 Weeks
Drug: Comparator: metronidazole / Duration of Treatment: 8 Weeks

Study Arms / Comparison Groups

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.

* 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

Completed

Enrollment ^ICMJE

300

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00481702

Responsible Party

Study ID Numbers ^ICMJE

2007_558

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

October 2007

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