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临床试验/NCT03264911
NCT03264911Unknown4 期

Group A Streptococcal Pharyngitis: Six Days Amoxicillin, oR Six Days Placebo in Children Between 3 and 15 Years Old:a Randomized, Double Blinded, Multicentred, Non-inferiority Trial

Klara Posfay-Barbe1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2017年1月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
360
试验地点
1
主要终点
Non inferiority

研究概览

简要总结

Evaluate the necessity to treat with antibiotics GAS pharyngitis in children in Switzerland. The null hypothesis is that antibiotic treatment is not necessary for GAS pharyngitis in this population.

详细描述

All children between 3 -15 years old with clinical symptoms suggestive of pharyngitis (Mc Isaac score ≥3) and a microbiological test (rapid antigen detection) positive for group A Streptococcus (GAS) will be included in the study. In order to assess the strain of GAS as well as to identify co-infected children with respiratory virus, a throat culture and a nasopharyngeal swab will be performed, as well as a standard questionnaire and a standard physical exam. At this time, children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment. During the treatment period, the investigators will ask the parents/legal guardians of the patients to pay close attention to the evolution of the symptoms (fever, pain, exudates...) as well as the treatment's adverse event, and to report their presence or absence in a dairy form. At day three after initiation of treatment, a standardized clinical evaluation will be completed by phone to identify if the patient still has symptoms of pharyngitis or signs of suppurative complications. One month after the inclusion in the study, a throat culture, a standardized questionnaire as well as a clinical evaluation will be performed to identify if the patient has or had signs of non-suppurative complications and non-resolving infection. Six month and one year after inclusion, a phone call will evaluate the possible relapses, recurrences and complications of GAS infection with a standardized questionnaire. GAS strains will be analyzed to identify their unique fingerprint and viral coinfections will be reported to possibly identify cofactors for increased complication rates.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 3 -15 years old
  • Clinical symptoms suggestive of pharyngitis with MC Isaac score ≥3
  • Rapid-antigen detection test (RADT) positive for GAS-
  • Signed informed parental/patient consent form

排除标准

  • Hypersensitivity to B-lactams
  • concomitant disease which must be treated with antibiotics
  • chronic disease-Immunocompromised
  • Antibiotics within 72 h
  • history of ARF,scarlet fever,impetigo,acute glomerulonephritis
  • Family history of ARF
  • Complicated pharyngitis

研究组 & 干预措施

amoxicillin

Active Comparator

Children will be randomized to receive, after consent to the study, an antibiotic (amoxicillin approximately 50 mg/kg/day) orally, twice a day for 6 days.

干预措施: Amoxicillin or Placebo (Drug)

Placebo arm

Placebo Comparator

Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days.

干预措施: Amoxicillin or Placebo (Drug)

结局指标

主要结局

Non inferiority

时间窗: up to 1 month

Duration of fever and other clinical signs/symptoms in not treated children versus treated

次要结局

  • non-suppurative complications(1 year)
  • Number of consultations for pharyngitis(1 year)
  • suppurative complications(1 year)
  • eradication(1 month)
  • co-infections(at inclusion)
  • GAS strains(1 month)

研究者

发起方
Klara Posfay-Barbe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Klara Posfay-Barbe

Head of Pediatric Infectious Diseases

University Hospital, Geneva

研究点 (1)

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