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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00481702

Enrollment

300

Registered

2007-06-04

Start date

2001-12-31

Completion date

2003-06-30

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-abdominal Infection

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.

Interventions

DRUGComparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks

DRUGMK0826, /Duration of Treatment : 8 Weeks

DRUGComparator: metronidazole / Duration of Treatment: 8 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection	2 weeks after treatment

Secondary

Measure	Time frame
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection	4 weeks after treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026