DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 appendicitis

QOL 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.


Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017