A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)

Intra-abdominal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481702
• Other study ID #: 0826-802
• Secondary ID: 2007_558
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2007
• Last updated: February 17, 2017
• Start date: December 2001
• Est. completion date: June 2003

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intra-abdominal Infection
• Intraabdominal Infections

Intervention

Drug:
• Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks

• MK0826, /Duration of Treatment : 8 Weeks

• Comparator: metronidazole / Duration of Treatment: 8 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection		2 weeks after treatment
Secondary	That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection		4 weeks after treatment