Overview

This trial is active, not recruiting.

Condition acute uncomplicated appendicitis
Treatments 1 gm iv ertapenem at enrollment, 1 gm iv ertapenem at day 2 and oral metronidazole and cefdinir to complete 10 days, appendectomy
Phase phase 0
Sponsor Olive View-UCLA Education & Research Institute
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2014
End date October 2015
Trial size 30 participants
Trial identifier NCT02447224, 1R21DK102048

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.
1 gm iv ertapenem at enrollment
1 gm iv ertapenem at day 2 and oral metronidazole and cefdinir to complete 10 days
(Active Comparator)
Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.
1 gm iv ertapenem at enrollment
appendectomy

Primary Outcomes

Measure
Major Complications
time frame: 30 days

Secondary Outcomes

Measure
Recurrent appendicitis
time frame: 30 days
QOL outcomes
time frame: 30 days

Eligibility Criteria

Male or female participants at least 5 years old.

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.

Additional Information

Official title A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Olive View-UCLA Education & Research Institute.