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
調査の概要
詳細な説明
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In case of hypersensitivity to antibiotic administered the patient will be withdrawn from the study.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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Nadège ALGANS
- 電話番号：0561777204
- メール：algans.n@chu-toulouse.fr
研究場所
-
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Bordeaux、フランス
- CHU de Bordeaux - Pellerin
-
コンタクト：
- Luke HARPER
- メール：luke.harper@chu-bordeaux.fr
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主任研究者：
- Luke HARPER
-
Grenoble、フランス
- Centre Hopsitalier Universitaire de Grenoble - Hôpital Nord
-
コンタクト：
- Romain FAGUET
- メール：Rfaguet@chu-grenoble.fr
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主任研究者：
- Romain FAGUET
-
Lille、フランス
- Centre Hospitalier Universitaire de Lille - Hôpital Salengro
-
主任研究者：
- Francois DUBOS
-
コンタクト：
- Francois DUBOS
- メール：francois.dubos@chu-lille.fr
-
Limoges、フランス
- Centre Hospitalier Universitaire de Limoges
-
コンタクト：
- Quentin BALLOUHEY
- メール：Quentin.Ballouhey@chu-limoges.fr
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主任研究者：
- Quentin BALLOUHEY
-
Marseille、フランス
- AP-HM Hôpital Nord
-
コンタクト：
- Anne DARIEL
- メール：anne.dariel@ap-hm.fr
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主任研究者：
- Anne DARIEL
-
Montpellier、フランス
- Centre Hospitalier Universitaire - Hôpital Lapeyronie
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コンタクト：
- Nicolas KALFA
- メール：n-kalfa@chu-montpellier.fr
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主任研究者：
- Nicolas KALFA
-
Nantes、フランス
- Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
-
コンタクト：
- Marc-David LECLAIR
- メール：mdleclair@chu-nantes.fr
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主任研究者：
- Marc-David LECLAIR
-
Paris、フランス
- AP-HP Hôpital Trousseau
-
コンタクト：
- Sabine IRTAN
- メール：sabine.irtan@aphp.fr
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主任研究者：
- Sabine IRTAN
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Rennes、フランス
- Centre Hospitalier Régional Universitaire de Rennes
-
コンタクト：
- Alexis ARNAUD
- メール：alexis.arnaud@chu-rennes.fr
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主任研究者：
- Alexis ARNAUD
-
Toulouse、フランス
- Centre Hospitalier Universitaire
-
コンタクト：
- Isabelle KIEFFER
- メール：kieffer.i@chu-toulouse.fr
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コンタクト：
- Gwenaelle ALPHONSA
- メール：alphonsa.g@chu-toulouse.fr
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主任研究者：
- Olivier ABBO
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
children in the arm NOT
|
|
他の：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.
|
children in usual care in arm Surgery
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of treatment-related failures at one year
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Initial success rate
時間枠：Day 12
|
Day 12
|
|
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Direct Medical costs, and indirect costs (parental absenteeism) descriptions
時間枠：Month 12
|
Month 12
|
|
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Rehospitalization, appendectomy
時間枠：from Day 1 to Year 5
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Using consumption data available in SNDS database, describe child care pathways over 5 years
|
from Day 1 to Year 5
|
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Incidence of adverse events
時間枠：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
時間枠：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)
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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
時間枠：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.
|
協力者と研究者
捜査官
- スタディディレクター：Olivier ABBO、University Hospital of Toulouse
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RC31/24/0320
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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