NCT02447224

Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Olive View-UCLA Education & Research Institute · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.

Detailed description

This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.

Conditions

• Acute Uncomplicated Appendicitis

Interventions

Type	Name	Description
DRUG	1 gm IV ertapenem at enrollment
DRUG	1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days
PROCEDURE	Appendectomy

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2017-12-31
• First posted: 2015-05-18
• Last updated: 2018-04-10

Locations

1 site across 1 country: United States