One Versus Five Days of Antibiotics After Appendectomy

Summary

The goal of this clinical trial is to learn if a one-day course of antibiotics after appendectomy surgery works as well as a five-day course to prevent infections in children and adults (aged 10 years and older) with uncomplicated acute appendicitis (non-ruptured, non-gangrenous appendix). The main questions it aims to answer are: * Does a one-day antibiotic regimen result in a similar rate of surgical site infections, intra-abdominal abscesses, or death within 30 days after surgery compared to a five-day regimen? * What is the rate of hospital readmission, antibiotic-related side effects, and cost-effectiveness for each treatment duration? Researchers will compare participants receiving 24 hours of intravenous antibiotics to participants receiving 5 days of antibiotics (1 day intravenous followed by 4 days oral) to see if the shorter course is non-inferior (not meaningfully worse) to the longer standard course. Participants will: * Undergo appendectomy for uncomplicated acute appendicitis * Be randomly assigned to receive either one day or five days of postoperative antibiotics * Receive follow-up at 30 days after surgery, including a telephone call to check for infections, readmissions, or other complications * Allow study staff to collect information from their medical records regarding hospital stay, antibiotic side effects, and any need for reoperation or restarting antibiotics

Timeline

Start

2026-05-01

Primary completion

2026-10-30

Completion

2027-04-30

Publications

• Background Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
• Background Mazuski JE, Sawyer RG, Nathens AB, DiPiro JT, Schein M, Kudsk KA, Yowler C; Therapeutic Agents Committee of the Surgical Infections Society. The Surgical Infection Society guidelines on antimicrobial therapy for intra-abdominal infections: evidence for the recommendations. Surg Infect (Larchmt). 2002 Fall;3(3):175-233. doi: 10.1089/109629602761624180.
• Background Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.
• Background Dyar OJ, Huttner B, Schouten J, Pulcini C; ESGAP (ESCMID Study Group for Antimicrobial stewardshiP). What is antimicrobial stewardship? Clin Microbiol Infect. 2017 Nov;23(11):793-798. doi: 10.1016/j.cmi.2017.08.026. Epub 2017 Sep 4.
• Results Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.
• Results Sawyer RG, Claridge JA, Nathens AB, Rotstein OD, Duane TM, Evans HL, Cook CH, O'Neill PJ, Mazuski JE, Askari R, Wilson MA, Napolitano LM, Namias N, Miller PR, Dellinger EP, Watson CM, Coimbra R, Dent DL, Lowry SF, Cocanour CS, West MA, Banton KL, Cheadle WG, Lipsett PA, Guidry CA, Popovsky K; STOP-IT Trial Investigators. Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015 May 21;372(21):1996-2005. doi: 10.1056/NEJMoa1411162.

Drugs

Indications

No indication recorded.