NCT00195923

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 6, 2007

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

April 5, 2007

Conditions

Perforated Appendicitis

Keywords

appendicitisperforation

Interventions

Ampicillin, gentamicin, clindamycin, flagyl, ceftazidimeDRUG

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

AmpicillinGentamicinsClindamycinMetronidazoleCeftazidime

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Penicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAminoglycosidesGlycosidesCarbohydratesLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingNitroimidazolesNitro CompoundsImidazolesAzolesCephaloridineCephalosporinsThiazines

Study Officials

  • Daniel J Ostlie, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2005

Study Completion

January 1, 2007

Last Updated

April 6, 2007

Record last verified: 2005-09

Locations

US(1)