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

19 maggio 2026 aggiornato da: University Hospital, Toulouse

Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children: a Prospective Multicenter Randomized Controlled Non-inferiority Trial With Cost Utility Analysis

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The design of the NACAC study is an open-label, randomized, multicenter controlled non-inferiority trial with 2 parallel groups: one group of patients will have appendectomy (ST), and the other group will receive antibiotic treatment (NOT).

Children in the non-operative treatment group will be hospitalised for clinical monitoring with initiation of antibiotic therapy at day 1 with Amoxicillin/clavulanic acid IntraVeinous (IV) in 2 doses daily for a minimum of 24 hours and a maximum of 48 hours with a relay of Amoxicillin/clavulanic acid Per Os (PO) in 2 doses daily, for a total of 7 days (IV and PO).

Children can be discharged from hospital after day 1 if the clinical conditions are safe.

In case of hypersensitivity to antibiotic administered the patient will be withdrawn from the study.

Children randomised to the Surgical Treatment group will be hospitalised for a surgical usual management within 24 hours, according to the surgical unit organisation.

For all patients a physical examination (same as inclusion) will be made by an investigator at Day 1 and discharge. Questionnaires will be assessed at D1 and discharge. At discharge, parental absenteism will be evaluated. For ST group, possible post-operative complication will also be evaluated. A visit on the investigator site from Day 10 to Day 15 : all the patients will have a complete physical examination (same as inclusion), child activity evolution and parental absenteeism will be evaluated.

An abdominal ultrasound or CT scan will be performed in patients randomized in the non-operative treatment group. AE and concomitant treatment will be assessed at this study visit by questioning, during the physical examination of the patient.

Compliance to study treatment will be reviewed at day 12 in the NOT group. For ST group, possible post-operative complication will also be evaluated.

At Month 1 (D30), Month 6 (M6) and Month 12 (M12) investigator will realize phone visits in order to :

Get safety aspects related to antibiotic treatment and treatment-related failures at month 1, six months and one year, notably, secondary surgery and in ST group, a complication requiring anew general anaesthesia or possible post-operative complication, will be recorded.

Child activity evolution and parental absenteeism will also be recorded. AE and concomitant treatment will be recorded. A Cost-Utility analysis will be performed from the healthcare payer's perspective.This medico anlysis will need Direct medical costs collection based on security social system.

Tipo di studio

Interventistico

Iscrizione (Stimato)

724

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Francia
      • Bordeaux, Francia
      • Grenoble, Francia
        • Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord
        • Contatto:
        • Investigatore principale:
          • Romain FAGUET
      • Lille, Francia
        • Centre Hospitalier Universitaire de Lille - Hôpital Salengro
        • Investigatore principale:
          • Francois DUBOS
        • Contatto:
      • Limoges, Francia
      • Marseille, Francia
        • AP-HM Hopital Nord
        • Contatto:
        • Investigatore principale:
          • Anne DARIEL
      • Montpellier, Francia
        • Centre Hospitalier Universitaire - Hôpital Lapeyronie
        • Contatto:
        • Investigatore principale:
          • Nicolas KALFA
      • Nantes, Francia
        • Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
        • Contatto:
        • Investigatore principale:
          • Marc-David LECLAIR
      • Paris, Francia
        • AP-HP Hôpital Trousseau
        • Contatto:
        • Investigatore principale:
          • Sabine IRTAN
      • Rennes, Francia
        • Centre Hospitalier Régional Universitaire de Rennes
        • Contatto:
        • Investigatore principale:
          • Alexis ARNAUD
      • Toulouse, Francia

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • On going antibiotherapy : previous antibiotherapy have to be stopped at least 48h before inclusion
  • 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
  • Mental state rendering the person giving consent incapable of understanding the trial
  • Parents being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators
  • Renal insufficiency with creatinine clearance < 30mL/min
  • Presence of an appendicolith

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Non Operative Treatment Group
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.
Droga: Amoxi Clavulanate
children in the arm NOT
Altro: Surgery Treatment Group
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.
Procedura: appendicectomy
children in usual care in arm Surgery

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of treatment-related failures at one year
Lasso di tempo: 12 months
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Initial success rate
Lasso di tempo: Day 12
Day 12
Direct Medical costs, and indirect costs (parental absenteeism) descriptions
Lasso di tempo: Month 12
Month 12
Rehospitalization, appendectomy
Lasso di tempo: from Day 1 to Year 5
Using consumption data available in SNDS database, describe child care pathways over 5 years
from Day 1 to Year 5
Incidence of adverse events
Lasso di tempo: At Month 1 and Month 12
in the two groups, and incidence of adverse events due to antibiotics in the NOT group
At Month 1 and Month 12
Score of quality of life with the questionnaire EQ-5D-Y-3L for children
Lasso di tempo: Day 1, Month 1 and Month 12.
0 is the worst score and 1 the better score (it is possible to have very bad values under 0)
Day 1, Month 1 and Month 12.
Score of of quality of life with the questionnaire EQ-5D-5L for parents
Lasso di tempo: Day 1, Month 1 and Month 12.
0 is the worst score and 1 the better score (it is possible to have very bad values under 0)
Day 1, Month 1 and Month 12.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Toulouse

Investigatori

  • Direttore dello studio: Olivier ABBO, University Hospital of Toulouse

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2029

Completamento dello studio (Stimato)

1 settembre 2034

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RC31/24/0320

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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