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Completed

NCT Number: NCT00092170

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

  1. 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.

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