Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis
Information source: Olive View-UCLA Education & Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Uncomplicated Appendicitis
Intervention: 1 gm IV ertapenem at enrollment (Drug); 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days (Drug); Appendectomy (Procedure)
Phase: Phase 0
Status: Recruiting
Sponsored by: Olive View-UCLA Education & Research Institute Overall contact:
David A Talan, MD, Phone: 818-364-3107, Email: dtalan@ucla.edu
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.
Clinical Details
Official title: A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Major Complications
Secondary outcome: Recurrent appendicitisQOL outcomes
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.
Eligibility
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
David A Talan, MD, Phone: 818-364-3107, Email: dtalan@ucla.edu
Olive View-UCLA Medical Center, Sylmar, California 91342, United States; Recruiting
David Talan, MD, Phone: 818-364-3107, Email: dtalan@ucla.edu
Additional Information
Starting date: October 2014
Last updated: May 15, 2015
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