Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children (NACAC)
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
연구 개요
상세 설명
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In case of hypersensitivity to antibiotic administered the patient will be withdrawn from the study.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.
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Nadège ALGANS
- 전화번호: 0561777204
- 이메일: algans.n@chu-toulouse.fr
연구 장소
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Bordeaux, 프랑스
- CHU de Bordeaux - Pellerin
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연락하다:
- Luke HARPER
- 이메일: luke.harper@chu-bordeaux.fr
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수석 연구원:
- Luke HARPER
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Grenoble, 프랑스
- Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord
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연락하다:
- Romain FAGUET
- 이메일: Rfaguet@chu-grenoble.fr
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수석 연구원:
- Romain FAGUET
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Lille, 프랑스
- Centre Hospitalier Universitaire de Lille - Hôpital Salengro
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수석 연구원:
- Francois DUBOS
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연락하다:
- Francois DUBOS
- 이메일: francois.dubos@chu-lille.fr
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Limoges, 프랑스
- Centre Hospitalier Universitaire de Limoges
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연락하다:
- Quentin BALLOUHEY
- 이메일: Quentin.Ballouhey@chu-limoges.fr
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수석 연구원:
- Quentin BALLOUHEY
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Marseille, 프랑스
- AP-HM Hôpital Nord
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연락하다:
- Anne DARIEL
- 이메일: anne.dariel@ap-hm.fr
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수석 연구원:
- Anne DARIEL
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Montpellier, 프랑스
- Centre Hospitalier Universitaire - Hôpital Lapeyronie
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연락하다:
- Nicolas KALFA
- 이메일: n-kalfa@chu-montpellier.fr
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수석 연구원:
- Nicolas KALFA
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Nantes, 프랑스
- Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
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연락하다:
- Marc-David LECLAIR
- 이메일: mdleclair@chu-nantes.fr
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수석 연구원:
- Marc-David LECLAIR
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Paris, 프랑스
- AP-HP Hôpital Trousseau
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연락하다:
- Sabine IRTAN
- 이메일: sabine.irtan@aphp.fr
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수석 연구원:
- Sabine IRTAN
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Rennes, 프랑스
- Centre Hospitalier Régional Universitaire de Rennes
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연락하다:
- Alexis ARNAUD
- 이메일: alexis.arnaud@chu-rennes.fr
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수석 연구원:
- Alexis ARNAUD
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Toulouse, 프랑스
- Centre Hospitalier Universitaire
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연락하다:
- Isabelle KIEFFER
- 이메일: kieffer.i@chu-toulouse.fr
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연락하다:
- Gwenaelle ALPHONSA
- 이메일: alphonsa.g@chu-toulouse.fr
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수석 연구원:
- Olivier ABBO
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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children in the arm NOT
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다른: 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.
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children in usual care in arm Surgery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of treatment-related failures at one year
기간: 12 months
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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
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Initial success rate
기간: Day 12
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Day 12
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Direct Medical costs, and indirect costs (parental absenteeism) descriptions
기간: Month 12
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Month 12
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Rehospitalization, appendectomy
기간: from Day 1 to Year 5
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Using consumption data available in SNDS database, describe child care pathways over 5 years
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from Day 1 to Year 5
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Incidence of adverse events
기간: At Month 1 and Month 12
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in the two groups, and incidence of adverse events due to antibiotics in the NOT group
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At Month 1 and Month 12
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Score of quality of life with the questionnaire EQ-5D-Y-3L for children
기간: Day 1, Month 1 and Month 12.
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0 is the worst score and 1 the better score (it is possible to have very bad values under 0)
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Day 1, Month 1 and Month 12.
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Score of of quality of life with the questionnaire EQ-5D-5L for parents
기간: Day 1, Month 1 and Month 12.
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0 is the worst score and 1 the better score (it is possible to have very bad values under 0)
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Day 1, Month 1 and Month 12.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Olivier ABBO, University Hospital of Toulouse
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RC31/24/0320
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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