drugset / Trial / NCT07587450

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

NCT07587450

Phase 3 Not yet recruiting 724 enrolled University Hospital, Toulouse
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-09-01
Primary completion
2029-09-01
Completion
2034-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 80 mg/kg Intravenous
Subject Amoxicillin Other / unclassified 3 g Intravenous
Subject clavulanic acid Small molecule Intravenous

Indications