Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin in Children With Severe Tonsillitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- treatment efficacy
研究概览
简要总结
To compare intravenous Co-amoxiclav versus Benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness.
详细描述
Efficacy was measured through improvement (decrease in fever, settling lymphadenopathy and disappearance of tonsillar exudate) in Centor Criteria score on daily basis. Improvement i.e reduction in Centor Criteria score was recorded for all children till full recovery.
Safety was measured by frequency of hypersensitivity reactions or severe side effects of antibiotics necessitating stoppage of the drug. All the children in both Groups were given test dose of the antibiotic before giving full dose of antibiotic prescribed.
Cost effectiveness was compared in terms of total cost of injections (Co-amoxiclav versus Benzyl penicillin) which were administered to children in both groups.
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
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who had 3 or 4 score according to Centor Criteria for tonsillitis/pharyngotonsillitis, were included in study
- •Children between ages of 5 to 15 years
- •Children with positive Rapid Antigen detection Test (RADT) for Streptococcus Pyogenes
排除标准
- •Immunocompromised children
- •Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
- •Children with liver or renal failure
- •Children who were already using any oral or parenteral antibiotics
研究组 & 干预措施
Inj Co-amoxiclav
Group A children were advised Inj Co-amoxiclav 50 units/kg/day in 3 divided doses daily
干预措施: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day (Drug)
Inj Benzyl Penicillin
Group B patients were advised inj Benzyl Penicillin 25000 units/kg/day in 3 divided doses
干预措施: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day (Drug)
结局指标
主要结局
treatment efficacy
时间窗: 10 days
full recovery (Centor score became zero/nil)
次要结局
未报告次要终点
研究者
Ahmed Khan
ENT consultant
Combined Military Hospital, Pakistan