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

Sponsors

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
Condition
Intervention

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

Eligibility

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.

Gender:

All

Minimum Age:

5 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility: Olive View-UCLA Medical Center
Location Countries

United States

Verification Date

2018-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Olive View-UCLA Education & Research Institute

Investigator Full Name: David A. Talan

Investigator Title: Principal Investigator

Keywords
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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News