Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis

This study has been completed.

First Received: September 12, 2005 Last Updated: April 5, 2007 History of Changes

Sponsor:	Children's Mercy Hospital Kansas City
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00195923

Purpose

The purpose of this study is to compare traditional triple antibiotic therapy against dual single day dosing antibiotic therapy in the management of perforated appendicitis in children.

Condition	Intervention	Phase
Perforated Appendicitis	Drug: Ampicillin, gentamicin, clindamycin, flagyl, ceftazidime	Phase IV

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title:	Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Appendicitis

Drug Information available for: Ampicillin sodium Ampicillin Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Ceftazidime Gentamicins Ampicillin trihydrate

U.S. FDA Resources

Further study details as provided by Children's Mercy Hospital Kansas City:

Estimated Enrollment:	100
Study Start Date:	April 2005
Study Completion Date:	January 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Month to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients under 18 years of age found to have perforated appendicitis at the time of operation for appendicitis and whose parents give informed permission will be included in the study.

Exclusion Criteria:

Patients with a normal or non-perforated appendix at the time of appendectomy, those without parental permission, or those with a documented allergy to any of the antibiotics used in either regimen will be excluded from the study. Patients 18 years or older will not be included in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195923

Locations

United States, Missouri
The Children’s Mercy Hospital
Kansas CIty, Missouri, United States, 64108

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

Principal Investigator:

Daniel J Ostlie, MD

Children's Mercy Hospital

More Information

No publications provided

Study ID Numbers:	04-12-149
Study First Received:	September 12, 2005
Last Updated:	April 5, 2007
ClinicalTrials.gov Identifier:	NCT00195923 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:

appendicitis
perforation

Additional relevant MeSH terms:

Anti-Infective Agents
Clindamycin
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Ampicillin
Enzyme Inhibitors
Intestinal Diseases
Pharmacologic Actions
Cecal Diseases

Ceftazidime
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Digestive System Diseases
Appendicitis
Therapeutic Uses
Gentamicins
Gastroenteritis

ClinicalTrials.gov processed this record on November 22, 2009