Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

Early Phase 1

Completed

• Conditions: Acute Uncomplicated Appendicitis
• Interventions: Drug: 1 gm IV ertapenem at enrollment; Procedure: Appendectomy; Drug: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days

• Registration Number: NCT02447224
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-18
• Primary Completion: 2015-10
• Study Completion: 2017-12-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-08
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotics	1 gm IV ertapenem at enrollment	Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.
Appendectomy	1 gm IV ertapenem at enrollment	Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.
Appendectomy	Appendectomy	Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.
Antibiotics	1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days	Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.

Primary Outcome Measures

Name	Time	Method
Major Complications	30 days	The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.

Secondary Outcome Measures

Name	Time	Method
Recurrent appendicitis	30 days
QOL outcomes	30 days

Trial Locations

Locations (1)

Olive View-UCLA Medical Center; 🇺🇸 Sylmar, California, United States