The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial (CODA)
Appendicitis
About this trial
This is an interventional treatment trial for Appendicitis
Eligibility Criteria
Inclusion Criteria:
- Adult ≥18 years;
Clinical diagnosis of acute uncomplicated appendicitis (AUA) established by clinical care team, supported by any of the following usual care radiological tests (computed tomography (CT), ultrasound (US), and/or magnetic resonance imaging (MRI)). AUA is defined by the usual signs, symptoms, and imaging finding of appendicitis without:
- Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis);
- Radiologic findings of :
i. Free air; ii. Walled off fluid collection concerning for an abscess; iii. Significant amounts of intra-abdominal fluid throughout abdomen (i.e., more than trace fluid); or iv. Extent of inflammation or adjacent organ involvement on radiologic imaging such that appendectomy is relatively contraindicated.
- Ability to provide written or electronic informed consent in English or Spanish.
Exclusion Criteria:
- 1. Unable or unwilling to return or be contacted for clinical follow-up visits and/or research surveys;
- Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
- Evidence of severe sepsis or septic shock (e.g., new presumed sepsis-related organ dysfunction, elevated lactate, and/or fluid unresponsive hypotension);
- Conditions with altered immune response or at risk for bacterial seeding;
- Immunodeficiency (e.g., absolute neutrophil count <500/mm3, chronic immunosuppressive drugs, active chemotherapy or plans for chemotherapy in the following 30 days, or known acquired immune deficiency syndrome (AIDS) [cluster of differentiation 4 (CD4) count <200 or AIDS-defining illness within the last year] assessed by patient history);
- Uncompensated liver failure;
- Taking medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis);
- Malignancy, not in remission (ongoing chemotherapy patients excluded);
- Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening;
- Expected concurrent hemodialysis, peritoneal dialysis, or treatments using indwelling venous catheters;
- Recent (within 90 days) placement of surgical implant (e.g., pacemaker, joint prosthesis, mechanical valve);
- Indwelling Left Ventricular Assist Device (LVAD);
- Patients with another infection (e.g., pneumonia, urinary tract infection) that requires treatment with another antibiotic at baseline/screening;
- Concurrent illness that would otherwise mandate hospitalization outside of appendicitis and associated symptoms at baseline/screening;
Imaging findings of any of the following:
- Appendiceal soft-tissue mass;
- Imaging features of mucocele or tumor (e.g., appendix measuring ≥ 15mm in diameter and no other CT evidence of appendicitis);
- Concern for carcinomatosis on imaging; or
- Severe allergy or reaction (e.g., immediate urticaria or anaphylaxis) to all of the proposed antibiotics;
- Prior enrollment in the study or other investigational drug or vaccine while on study treatment;
- Abdominal/pelvic surgery in the past month; or
- More than seven hours have transpired since the patient received the first parenteral dose of antibiotics.
Sites / Locations
- Olive View-UCLA Medical Center
- Harbor-UCLA Medical Center
- University of Colorado Denver
- Rush University Medical Center
- University of Iowa Hospitals and Clinics
- Maine Medical Center
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Michigan Medicine- University of Michigan
- Henry Ford Health System
- University of Mississippi Medical Center
- New York University - Bellevue Hospital
- New York University - Tisch Hospital
- Columbia University Medical Center
- Weill Cornell Medicine
- The Ohio State University Medical Center
- Vanderbilt University Medical Center
- Lyndon B Johnson- Harris Health
- The University of Texas Health Science Center at Houston
- Providence Regional Medical Center Everett
- Harborview Medical Center
- Virginia Mason University Village Medical Center
- Swedish Medical Center- First Hill
- University of Washington Medical Center
- Madigan Army Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Antibiotics Therapy Arm
Appendectomy Arm
Patients in the antibiotics (abx) arm will receive a total of 10 days of abx, with a minimum of 24 hours using an IV abx formulation (administered in q8, q12, or q24 hour regimens with or without concurrent oral abx) followed by oral abx for the remainder of the 10 days. Patients will be offered a treatment regimen of abx based on guidelines published jointly by the Surgical Infection Society and the Infectious Disease Society of America. Any of the IV abx options (Single antibiotic-Cefoxitin, Ertapenem, Moxifloxicin, Tigecycline, Ticarcillin-Clavulanic Acid or Dual antibiotics-Metronidazole plus one of the following-Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, Levofloxacin) will be considered acceptable. After IV abx, a regimen of oral abx will be continued for a total treatment length of 10 days.
Patients in the appendectomy arm will have an appendectomy performed by an open or laparoscopic approach, depending on patient and surgeon preference. Prior to their operation, patients in this arm will receive one dose of antibiotics per currently accepted standards when appendicitis diagnosis is confirmed. Patients may also receive preoperative antibiotics per hospital standards for surgical infection prevention bundle.