A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intra-Abdominal Infection
Intervention: Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks (Drug); MK0826, /Duration of Treatment : 8 Weeks (Drug); Comparator: metronidazole / Duration of Treatment: 8 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
Secondary outcome: That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related 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.
Starting date: January 2002
Last updated: October 8, 2007
|
