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


Lead Sponsor: Olive View-UCLA Education & Research Institute

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source Olive View-UCLA Education & Research Institute
Brief 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.

Overall Status Completed
Start Date 2015-03-01
Completion Date 2017-12-31
Primary Completion Date 2015-10-01
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Major Complications 30 days
Secondary Outcome
Measure Time Frame
Recurrent appendicitis 30 days
QOL outcomes 30 days
Enrollment 30

Intervention Type: Drug

Intervention Name: 1 gm IV ertapenem at enrollment

Intervention Type: Drug

Intervention Name: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days

Arm Group Label: Antibiotics

Intervention Type: Procedure

Intervention Name: Appendectomy

Arm Group Label: Appendectomy



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.



Minimum Age:

5 Years

Maximum Age:


Healthy Volunteers:


Facility: Olive View-UCLA Medical Center
Location Countries

United States

Verification Date


Responsible Party

Type: Principal Investigator

Investigator Affiliation: Olive View-UCLA Education & Research Institute

Investigator Full Name: David A. Talan

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Antibiotics

Type: Experimental

Description: Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.

Label: Appendectomy

Type: Active Comparator

Description: Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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