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

19. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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In case of hypersensitivity to antibiotic administered the patient will be withdrawn from the study.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

Studientyp

Interventionell

Einschreibung (Geschätzt)

724

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Frankreich
      • Bordeaux, Frankreich
      • Grenoble, Frankreich
        • Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord
        • Kontakt:
        • Hauptermittler:
          • Romain FAGUET
      • Lille, Frankreich
        • Centre Hospitalier Universitaire de Lille - Hôpital Salengro
        • Hauptermittler:
          • Francois DUBOS
        • Kontakt:
      • Limoges, Frankreich
      • Marseille, Frankreich
      • Montpellier, Frankreich
        • Centre Hospitalier Universitaire - Hôpital Lapeyronie
        • Kontakt:
        • Hauptermittler:
          • Nicolas KALFA
      • Nantes, Frankreich
        • Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
        • Kontakt:
        • Hauptermittler:
          • Marc-David LECLAIR
      • Paris, Frankreich
        • AP-HP Hôpital Trousseau
        • Kontakt:
        • Hauptermittler:
          • Sabine IRTAN
      • Rennes, Frankreich
        • Centre Hospitalier Régional Universitaire de Rennes
        • Kontakt:
        • Hauptermittler:
          • Alexis ARNAUD
      • Toulouse, Frankreich

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Amoxi Clavulanate
children in the arm NOT
Sonstiges: 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.
Verfahren: appendicectomy
children in usual care in arm Surgery

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of treatment-related failures at one year
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Initial success rate
Zeitfenster: Day 12
Day 12
Direct Medical costs, and indirect costs (parental absenteeism) descriptions
Zeitfenster: Month 12
Month 12
Rehospitalization, appendectomy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Toulouse

Ermittler

  • Studienleiter: Olivier ABBO, University Hospital of Toulouse

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. September 2029

Studienabschluss (Geschätzt)

1. September 2034

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

14. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RC31/24/0320

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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