Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olive View-UCLA Education & Research Institute
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefdinir; Ertapenem; Metronidazole

Criteria

Inclusion Criteria:

• Adult or child ages ≥5 years;

• Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;

• Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and

• Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion Criteria:

• instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.