Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis

NCT02447224 | Completed Early Phase 1

• 1 other identifier: 1R21DK102048
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Uncomplicated Appendicitis

Keywords

appendicitis; non operative management; appendectomy

Outcome Measures

Primary Outcomes (1)

• Major Complications

  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.

  30 days

Secondary Outcomes (2)

• Recurrent appendicitis

  30 days

• QOL outcomes

  30 days

Study Arms (2)

Antibiotics

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.

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

Appendectomy

ACTIVE COMPARATOR

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

Interventions

1 gm IV ertapenem at enrollment DRUG

Antibiotics; Appendectomy

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

Antibiotics

Appendectomy PROCEDURE

Appendectomy

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Metronidazole; Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 18, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 31, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

US (1)