The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial

NACompletedINTERVENTIONAL
Enrollment

1,552

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

March 5, 2020

Study Completion Date

September 1, 2021

Conditions
Appendicitis
Interventions
DRUG

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

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.

PROCEDURE

Appendectomy

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

Trial Locations (25)

10016

New York University - Bellevue Hospital, New York

New York University - Tisch Hospital, New York

10032

Columbia University Medical Center, New York

10065

Weill Cornell Medicine, New York

37232

Vanderbilt University Medical Center, Nashville

39216

University of Mississippi Medical Center, Jackson

43210

The Ohio State University Medical Center, Columbus

48109

Michigan Medicine- University of Michigan, Ann Arbor

48202

Henry Ford Health System, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

60612

Rush University Medical Center, Chicago

77026

Lyndon B Johnson- Harris Health, Houston

The University of Texas Health Science Center at Houston, Houston

80045

University of Colorado Denver, Aurora

90509

Harbor-UCLA Medical Center, Torrance

91342

Olive View-UCLA Medical Center, Sylmar

98104

Harborview Medical Center, Seattle

98105

Virginia Mason University Village Medical Center, Seattle

98122

Swedish Medical Center- First Hill, Seattle

98195

University of Washington Medical Center, Seattle

98201

Providence Regional Medical Center Everett, Everett

98431

Madigan Army Medical Center, Tacoma

04102

Maine Medical Center, Portland

02118

Boston Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

University of Washington

OTHER

NCT02800785 - The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial | Biotech Hunter | Biotech Hunter