An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092170

Purpose

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.

Condition	Intervention	Phase
Infections Pelvic Infections	Drug: MK0826, ertapenem sodium Drug: Comparator: Ticarcillin/Clavulanate	Phase II

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Clavulanic acid Ertapenem L 749345 Ticarcillin Ticarcillin disodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study
Official 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

Further study details as provided by Merck:

Primary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	January 2002

Detailed Description:

The duration of treatment is 18 months.

Eligibility

Ages Eligible for Study:	3 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Immune problems
Kidney problems

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092170

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Yellin AE, Johnson J, Higareda I, Congeni BL, Arrieta AC, Fernsler D, West J, Gesser R. Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients. Am J Surg. 2007 Sep;194(3):367-74.

Study ID Numbers:	2004_062
Study First Received:	September 21, 2004
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00092170
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Intra-abdominal infections
Acute pelvic infections

Study placed in the following topic categories:

Ertapenem
Ticarcillin
Clavulanic Acid

Clavulanic Acids
Pelvic Infection
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009