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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 724
- 试验地点
- 10
研究概览
简要总结
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.
详细描述
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In case of hypersensitivity to antibiotic administered the patient will be withdrawn from the study.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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