Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

Olive View-UCLA Education & Research Institute

Status and phase: Completed; Early Phase 1

Conditions: Acute Uncomplicated Appendicitis

Treatments: Drug: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days; Drug: 1 gm IV ertapenem at enrollment; Procedure: Appendectomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02447224

1R21DK102048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Antibiotics

Experimental group

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.

Treatment:

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

Drug: 1 gm IV ertapenem at enrollment

Appendectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Appendectomy

Drug: 1 gm IV ertapenem at enrollment