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Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

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ClinicalTrials.gov Identifier: NCT02447224
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David A. Talan, 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.

Condition or disease Intervention/treatment Phase
Acute Uncomplicated Appendicitis Drug: 1 gm IV ertapenem at enrollment Drug: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days Procedure: Appendectomy Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
Actual Study Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antibiotics
Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy.
Drug: 1 gm IV ertapenem at enrollment
Drug: 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days
Active Comparator: Appendectomy
Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery.
Drug: 1 gm IV ertapenem at enrollment
Procedure: Appendectomy



Primary Outcome Measures :
  1. Major Complications [ Time Frame: 30 days ]
    The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization.


Secondary Outcome Measures :
  1. Recurrent appendicitis [ Time Frame: 30 days ]
  2. QOL outcomes [ Time Frame: 30 days ]


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447224


Locations
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United States, California
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342
Sponsors and Collaborators
Olive View-UCLA Education & Research Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Responsible Party: David A. Talan, Principal Investigator, Olive View-UCLA Education & Research Institute
ClinicalTrials.gov Identifier: NCT02447224     History of Changes
Other Study ID Numbers: 1R21DK102048 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by David A. Talan, Olive View-UCLA Education & Research Institute:
appendicitis
non operative management
appendectomy

Additional relevant MeSH terms:
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Cefdinir
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Metronidazole
Ertapenem
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents