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

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.

Completed

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Key information

Conditions

Infections Intraabdominal Infections Pelvic Infection Pelvic Infections

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The duration of treatment is 18 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Immune problems
Kidney problems

Treatment and study plan

MK0826, ertapenem sodium

Drug

Comparator: Ticarcillin/Clavulanate

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Sep 24, 2004
Registry last updated: Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed