2026-525355-93-00招募中3 期
PHASE III, OPEN-LABEL, RANDOMIZED, CONTROLLED, NON-INFERIORITY CLINICAL-TRIAL TO ASSESS THE EFFICACY AND SAFETY OF SHORT OUTPATIENT AMOXICILLIN REGIMENS IN CHILDREN WITH ACUTE STREPTOCOCCAL PHARYNGOTONSILLITIS (STOP – TRIAL)
Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus5 个研究点 分布在 1 个国家入组 500 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Relapse: patients with reinfection by EbhGA within 15 days after completing the assigned antibiotic regimen.
研究概览
简要总结
Prospectively and randomly evaluate that the short 5-day course of oral amoxicillin is not inferior to the 7-day course with regard to the incidence of relapses in patients aged 2 to 17 years with streptococcal FAA.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- Male or female patients aged ≥2 years and <18 years
- Patients with a new diagnosis of FAA due to EbhGA confirmed microbiologically by TDR with onset of symptoms no more than 72 hours prior to the start of study treatment.
- McIsaac scale greater than or equal to 3 points provided there is a fever >38°C
- Written informed consent obtained from parents or legal guardians and assent from patients aged 12 years or older
排除标准
- Being treated with antibiotics whose spectrum of action includes EbhGA (penicillin, amoxicillin, amoxicillin-clavulanic acid, macrolides or first-, second- or third-generation cephalosporins).
- Impossibility of follow-up
- Patients allergic to amoxicillin
- Parents/legal guardians and/or patients who are unable to understand or comply with all the instructions and requirements of the study
- If, in the opinion of the investigator, there are findings in the physical examination, abnormalities in the clinical test results, or other medical, social, or psychosocial factors whose participation could put the patient's health at risk
- Having received treatment with any of the following medications in the previous 48 hours: probenecid, allopurinol, tetracyclines, oral anticoagulants or methotrexate.
- Showing signs and/or symptoms of viral infection: rhinorrhoea, cough, conjunctivitis, dysphonia, acute stomatitis, ulcerative lesions or vesicles in the mouth and/or diarrhoea
- Recurrent AAD: seven or more episodes of acute tonsillitis per year in the last year, five or more episodes per year in the last two years, or three or more episodes per year in the last three years. In addition, each episode must meet at least one of the following criteria: purulent exudate on the tonsils, temperature >38°C, anterior cervical lymphadenopathy, positive culture for EbhGA
- FAA due to microbiologically documented EbhGA (rapid diagnostic test or throat culture) within 28 days prior to initial care
- Patients with a personal history of suppurative and non-suppurative complications following streptococcal FAA
- Patients with a personal history of invasive disease (bacteremia, meningitis) caused by EbhGA
- Immunocompromised patients
- Pregnant or breastfeeding women
研究组 & 干预措施
AMOXICILLIN
Test
干预措施: AMOXICILLIN (Drug)
结局指标
主要结局
Relapse: patients with reinfection by EbhGA within 15 days after completing the assigned antibiotic regimen.
Relapse: patients with reinfection by EbhGA within 15 days after completing the assigned antibiotic regimen.
次要结局
- Cure: number of patients with fever resolution 48 hours after starting the assigned antibiotic regimen.
- Suppurative complications. Suppurative complications are defined as: o Acute cellulitis. o Acute otitis media. o Acute sinusitis. o Acute mastoiditis. o Acute suppurative cervical adenitis. o Acute peritonsillar or retropharyngeal abscess. o Acute meningitis. o Acute cerebral abscess. o Acute thrombosis of the intracranial venous sinuses. o Acute streptococcal pneumonia. o Acute suppurative arthritis. o Acute osteomyelitis. o Acute liver abscess. o Acute endocarditis.
- Non-suppurative complications. Non-suppurative complications are defined as: o Acute rheumatic fever (Diagnostic criteria - Appendix B). o Acute post-streptococcal glomerulonephritis. o Acute post-streptococcal reactive arthritis. o Erythema nodosum. o Anaaphylactoid purpura. o PANDAS syndrome.
- New episodes of streptococcal FAA: presence of new episodes with TDR or positive throat culture for EbhGA during the 4-month follow-up period.
研究者
Gina Paola Mejía Abril
Scientific
Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
研究点 (5)
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标识符
- 欧盟试验编号
- 2026-525355-93-00
- 其他研究编号
- FIBHNJ-2025-001
日期
- 首次发布
- (3个月前)
- 研究完成日期
- (6个月后)
- 最近更新
- (3个月前)
监管与共享
- 是否有结果
- 否
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