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
Verified date | February 2017 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
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
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 |
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