One Versus Five Days of Antibiotics After Appendectomy

NCT07563933 | Not Yet Recruiting

• 2 other identifiers: 11-2025/2311-2025/2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Post Operative Antibiotic Therapy of Acute Appendicitis

Keywords

acute appendicitis post operative therapy

Outcome Measures

Primary Outcomes (3)

• Rate of Surgical Site Infection (SSI)

  The proportion of participants diagnosed with a surgical site infection (superficial incisional, deep incisional, or organ/space) within 30 days following appendectomy. Diagnosis will be based on CDC criteria.

  Within 30 days post-appendectomy

• Rates of Intra-abdominal Abscess (IAA)

  The proportion of participants diagnosed with an intra-abdominal abscess.

  Within 30 days (± 3 days) post-appendectomy.

• Rate of All-Cause Mortality

  The proportion of participants who die from any cause within 30 days following appendectomy.

  Within 30 days post-appendectomy

Secondary Outcomes (1)

• Rate of Hospital Readmission

  Within 30 days post-appendectomy

Study Arms (2)

a one day (24 hours) post operative antibiotic

ACTIVE COMPARATOR

• Short course (guideline course): 24 hours of postoperative IV antibiotics (ampicillin/sulbactam)

Drug: a single day (24 hours) post operative

a five day post operative antibiotic

PLACEBO COMPARATOR

• Standard course (current applicable course): 1days of postoperative IV antibiotics (amoxicillin /clavulanic acid) followed by 4 days of oral antibiotic (amoxicillin /clavulanic acid).

Drug: a single day (24 hours) post operative

Interventions

a single day (24 hours) post operative DRUG

• Short course (guideline course): 24 hours of postoperative IV antibiotics (ampicillin/sulbactam)

a five day post operative antibiotic; a one day (24 hours) post operative antibiotic

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged ≥10 years.
• Undergoing appendectomy with intraoperative diagnosis of straightforward acute appendicitis ( non-phlegmonous, non-gangrenous, non-perforated, no abscess).

You may not qualify if:

• Complex appendicitis (gangrenous, perforated, abscess).
• Severe sepsis at presentation.
• Immunocompromised state ( including diabetic patients ).
• Pregnancy.
• Allergy to study antibiotics.
• Concurrent infections requiring antibiotics.

Sponsors & Collaborators

• Ministry of Health and Population, Egypt: lead

Study Sites (1)

Fayoum General Hospital

Al Fayyum, 63511, Egypt

Location

Related Publications (6)

• 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.

  PMID: 27437029 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.

  PMID: 12542923 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. Erratum In: Lancet. 2017 Oct 14;390(10104):1736. doi: 10.1016/S0140-6736(17)31502-7.

  PMID: 26460662 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.

  PMID: 28882725 BACKGROUND

• 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.

  PMID: 28178770 RESULT

• 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.

  PMID: 25992746 RESULT

Related Links

• Global action plan on antimicrobial resistance. World Health Organization. 2015
• Prospective Observational Study on acute Appendicitis Worldwide (POSAW).
• The New Antibiotic Mantra-"Shorter Is Better." JAMA Intern Med \[Internet\]. 2016 Sep 1 \[cited 2025 Jul 21\];176(9):1254
• Association of adverse events with antibiotic use in hospitalized patients. JAMA Intern Med \[Internet\]. 2017 Sep 1
• Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015;372(21):1996-2005.
• WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016;11(1).

MeSH Terms

Interventions

Postoperative Period

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Shahinda kamal, BSc Pharmacy

  Fayoum General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa M Rohym, MSc Epid

CONTACT

+2 01005686995; asmarohym123@gmail.com

shaimaa A Gebili, MSc Epid

CONTACT

+2 01003821248; shimaa_gebelly@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: no other parties are masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of clinical research department

Model Details: This randomized controlled non-blinded non-inferiority trial will be conducted at Fayoum General Hospital. The study sample will be patients aged ≥8 years who are admitted to The General Surgery Department to undergo appendectomy for straightforward acute appendicitis. A total of 100 patients will be randomized using computer -based randomization by1:1 to receive either a single day (24 hours) or five days of postoperative intravenous antibiotics. The primary outcome is a composite of infectious complications (surgical site infections \[SSI\] and intra-abdominal abscesses \[IAA\]) or mortality within 30 days post-surgery. Secondary outcomes include readmission rates, antibiotic-related adverse events , and cost-effectiveness. The non-inferiority margin is set at 5%. Analyses will be performed both per-protocol and intention-to-treat.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)