A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)

A Prospective, Multicenter, Open, Randomized, Comparative Study to Evaluate the Safety and Efficacy of Ertapenem Versus it's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00157898

Enrollment

134

Registered

2005-09-12

Start date

2004-01-31

Completion date

2004-09-30

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

Complicated Intra-abdominal Infection

Brief summary

This was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.

Interventions

DRUGMK0826; ertapenem sodium

DRUGComparator: ceftriaxone + metronidazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.

Design outcomes

Primary

Measure	Time frame
Favorable clinical response at 7-14 days after treatment	—

Secondary

Measure	Time frame
Favorable microbiologic response at 7-14 days after treatment	—

Outcome results

None listed

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