Treatment of Pharyngitis Study (TOPS): A Randomized Equivalence Trial of Intramuscular Penicillin G vs. Oral Amoxicillin Antibiotics for the Treatment of Streptococcal Pharyngitis in Children in Developing Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 558
- 试验地点
- 3
- 主要终点
- Eradication of Group A Streptococcus (GAS)
研究概览
简要总结
The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 2-12 years old,
- •Presenting with complaint of sore throat
- •Parental consent given and child assent if 5 years or older
排除标准
- •The parent/guardian reported oral antibiotic use in the past 3 days or injectable penicillin in past 28 days prior to screening
- •Had a history of rheumatic fever or rheumatic heart disease
- •Required hospitalization for any reason at the time of enrollment
- •Had previously been enrolled in the study
研究组 & 干预措施
Intramuscular benzathine Penicillin G
A single dose of intramuscularly administered intramuscular benzathine penicillin G (IM BPG). The dosing was as follows: IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg
干预措施: Penicillin G, Benzathine (Drug)
Amoxicillin
A 10-day once daily dose of Amoxicillin was given in an oral form. The first dose was given at the time of randomization, and parents were instructed on giving the remaining doses. Dosing was as follows: 750 mg/QD
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Eradication of Group A Streptococcus (GAS)
时间窗: 21-28 days after 1st visit
The primary outcome of the study was bacteriologic treatment success, which was defined as eradication of GAS from the pharynx at the follow up visit. Eradication was defined as no GAS present on the throat culture.
次要结局
- Compliance to treatment(21-28 days after 1st visit)