CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,552 enrolled
Drug / intervention
Cefoxitin, Ertapenem, Moxifloxacin, Tigecycline, Ticarcillin-Clavulanic Acid; Metronidazole plus Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, or Levofloxacin +1 moredrug
Likely dose
Not stated in record
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NCT02800785N/ACompleted
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The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial

University of Washington·interventional·Posted Jun 15, 2016·Updated May 6, 2023

In Brief

A clinical study evaluating Cefoxitin, Ertapenem, Moxifloxacin, Tigecycline, Ticarcillin-Clavulanic Acid; Metronidazole plus Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, or Levofloxacin and Appendectomy for Appendicitis. Completed, enrolled 1,552 participants across 25 sites.

Detailed Summary

For the past 130 years, appendectomy has been the standard treatment for appendicitis. Recent studies from Europe have challenged the notion that surgery is the best option, showing that antibiotics alone can treat appendicitis without a need for appendectomy in as many as 3 out of 4 patients and without safety issues for up to one year of follow up. Despite these results, it remains to be determined if the antibiotic strategy is as good as an appendectomy for the outcomes that most patients care about. The Patient-Centered Outcomes Research Institute (PCORI)-funded Comparison of Outcomes of Drugs and Appendectomy (CODA) trial will be the first American, and largest-ever randomized trial of the issue and its results should help surgeons and patients make more informed healthcare decisions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAppendicitis
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 15, 2016
Enrollment StartMay 1, 2016
Primary CompletionMar 5, 2020
Study CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.0 years ago

Interventions

Cefoxitin, Ertapenem, Moxifloxacin, Tigecycline, Ticarcillin-Clavulanic Acid; Metronidazole plus Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, or Levofloxacindrug

Patients will be offered a treatment regimen of antibiotics based on guidelines published jointly by the Surgical Infection Society and the Infectious Disease Society of America. After IV antibiotics are administered for a period of at least 24 hours, a regimen of oral antibiotics will be continued for a total treatment length of 10 days. Preferred oral antibiotic regimens include Moxifloxacin alone, and combinations such as Metronidazole or Clindamycin, for anaerobic bacteria coverage, plus Ciprofloxacin or Levofloxacin, or an oral Cephalosporin for aerobic Gram-negative bacteria coverage.

Appendectomyprocedure

Appendectomy will be performed by an open or laparoscopic approach, depending on patient and surgeon preference.