An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)

A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Ertapenem Sodium ( MK0826) Versus Ticarcillin/Clavulanate in the Treatment of Hospital-Acquired Pneumonia, Complicated Intra-Abdominal Infections, and Acute Pelvic Infections in Pediatric Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092170

Enrollment

100

Registered

2004-09-24

Start date

2002-03-31

Completion date

2004-01-31

Last updated

2017-02-17

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

Conditions

Infections, Pelvic Infections

Keywords

Intra-abdominal infections, Acute pelvic infections

Brief summary

The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.

Detailed description

The duration of treatment is 18 months.

Interventions

DRUGMK0826, ertapenem sodium

DRUGComparator: Ticarcillin/Clavulanate

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 17 Years

Healthy volunteers

Inclusion criteria

* Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection

Exclusion criteria

* Immune problems * Kidney problems

Design outcomes

Primary

Measure	Time frame
Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy	—

Outcome results

None listed

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