Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children

NCT07587450 | Not Yet Recruiting Phase 3

• 1 other identifier: RC31/24/0320
• Study Type: interventional
• Target: 724
• Locations: 1 country
• Sites: 10

Brief Summary

The majority of children with uncomplicated acute appendicitis may be considered for either a non-operative or an operative management. The antibiotic-first strategy appears effective as an initial treatment in 97% of children with uncomplicated AA (recurrence rate 14%), with Non Operative Treatment (NOT) also leading to less morbidity, fewer disability days, and lower costs than surgery. In this trial, the investigators will compare children randomised in a surgery group with children randomised in a NOT group (antibiotic strategy group). Children have 2 on-site visits (including surgery) in the first 12 days with recording of clinical datas and questionnaires, a phone visit at month 1, month 6, month 12 to collect concomitant treatment, Adverse Event (AE) and complications and parental questionnaires at the end of the study. A Cost-Utility analysis will be performed from the healthcare payer's perspective. The time horizon of the medico economic analysis was one year.

Conditions

Acute Uncomplicated Appendicitis

Keywords

surgery; antibiotics therapy; medico - economic analysis

Outcome Measures

Primary Outcomes (1)

• Percentage of treatment-related failures at one year

  readmissions for suspicion of appendicitis, secondary surgery, emergency visits related to appendicitis management, postoperative infections, side effects of antibiotics, adverse events of anesthesia. In surgery group, a normal appendix based on pathology or a complication requiring a new general anaesthesia

  12 months

Secondary Outcomes (6)

• Initial success rate

  Day 12

• Score of quality of life with the questionnaire EQ-5D-Y-3L for children

  Day 1, Month 1 and Month 12.

• Score of of quality of life with the questionnaire EQ-5D-5L for parents

  Day 1, Month 1 and Month 12.

• Direct Medical costs, and indirect costs (parental absenteeism) descriptions

  Month 12

• Rehospitalization, appendectomy

  from Day 1 to Year 5

Study Arms (2)

Non Operative Treatment Group

EXPERIMENTAL

Children randomised in this group are treated by antibiotic therapy : 80mg/kg/day of amoxicillin for patients weighing less than 40 kg and 3 g/day for those weighing 40 kg or more)with a relay of Amoxicillin/clavulanic acid (80mg/kg/day for patients weighing less than 40 kg and 3 g/day for those weighing 40 kg or more) PO in 2 doses daily, for a total antibiotictreatment (IV and PO) of 7 days.

Drug: Amoxi Clavulanate

Surgery Treatment Group

OTHER

Children randomised in this group the child will undergo appendectomy within 24 hours, according to surgical unit organization. No antibiotics will be administered before surgery.

Procedure: appendicectomy

Interventions

Amoxi Clavulanate DRUG

children in the arm NOT

Non Operative Treatment Group

appendicectomy PROCEDURE

children in usual care in arm Surgery

Surgery Treatment Group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 5 to \<15 years-old
• Diagnosis of first episode of acute uncomplicated appendicitis confirming the diagnosis:
• an increase in the calibre of the appendix, measured at more than 6 mm in diameter and non-compressibility
• free fluid, echogenic fat, regional hyperemia
• performed in hospital or reviewed by local radiologist investigators if performed outpatient.
• Surgery expected within 24 hours after diagnosis
• Parental good understanding of the monitoring French instructions
• Free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient.
• Affiliation to the health insurance plan

You may not qualify if:

• Ultrasound or CT scan showing one or several stercoliths, a plastron, an abscess or peritonitis
• Non-visualization of the appendix at ultrasound or CT scan
• Situations contraindicating surgery or anesthesia (patient for whom surgery and anesthesia would pose a life-threatening risk)
• Patients who have already received antibiotic therapy for acute appendicitis
• Known immunodepression, ongoing immunosuppressive treatment, diabetes
• Severe hematologic disorders (such as bone marrow failure, blood clotting disorders)
• History of proved allergy to Penicillin
• History of proved allergy to amoxicillin and/or clavulanic acid
• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
• History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid
• History of allergy to any of the excipients listed in section 6.1 of each SmPC.
• Parental refusal of research protocol
• Impossibility of home follow-up after discharge from hospital
• Pregnancy/ breastfeeding
• Simultaneously participation in another research study involving medicinal products

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (10)

CHU de Bordeaux - Pellerin

Bordeaux, France

Location

Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord

Grenoble, France

Location

Centre Hospitalier Universitaire de Lille - Hôpital Salengro

Lille, France

Location

Centre Hospitalier Universitaire de Limoges

Limoges, France

Location

AP-HM Hopital Nord

Marseille, France

Location

Centre Hospitalier Universitaire - Hôpital Lapeyronie

Montpellier, France

Location

Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu

Nantes, France

Location

AP-HP Hôpital Trousseau

Paris, France

Location

Centre Hospitalier Régional Universitaire de Rennes

Rennes, France

Location

Centre Hospitalier Universitaire

Toulouse, France

Location

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Appendectomy

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Olivier ABBO

  University Hospital of Toulouse

  STUDY DIRECTOR

Central Study Contacts

Nadège ALGANS

CONTACT

0561777204; algans.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2034
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (10)