comparison of efficacy of Albendazole, Mebendazole, pyrantel pamoate in achieving remission and preventing recurrence of enterobiusvermicularis infection in children using an objective remission and recurrence score - a randomized control trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- occurrence of remission in each of the arm by remission score
研究概览
简要总结
Children in the age group of 2-12 years with confirmed enterobiusvermicularis (pinworm)infection are randomized to receive albendazole ,mebendazole and pyrantel pamoate in a single dose with a repeat dose after 2 weeks. Family members of affected children are treated simultaneously. Every patient is given a hygiene diary with hygiene steps taught by principal investigator to parents and children.
Children and parents are interviewed again at 2 weeks; 4 weeks; 6 weeks and 8 weeks either as in person or through video consultation after completion of treatment to know about remission and at 1month , 2 months and 3 months post remission to know about recurrence of pinworms. Since pinworm is known for auto inoculation ,retrograde infection and chronic parasitism ,remission and recurrence scores of pinworm infection for the Albendazole , Mebendazole and Pyrantel pamoate groups are compared statistically to know their efficacy .The impact of hygiene in remission and recurrence is derived from the data in hygiene diaries.
The sample size was reworked with cure rates of Albendazole and Mebendazole from hook worm infection (similar helminth) since recent RCTs in pinworms are not available.The sample size came as 42 for each group. With the help from microbiology department,the worms are preserved in 75% ethyl alcohol and then seen under a microscope to confirm pinworms.Patients were included only after microscopic confirmation to rule out false positivity.Allocation concealment is ensured using serially numbered,opaque,sealed envelopes which are opened only after confirmation of participant eligibility.
All the above operational and methodological refinements were made during the implementation phase prior to the data collection and analysis ,while the core study objectives and predefined outcomes remained unchanged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •All children in age group of 2-12 years attending the pediatric outpatient department with pin worm infection.
- •pinworm infection is diagnosed by 3 methods 1]pin worms detected on clinical examination 2]parents or attendees accompanying children bring dead or live pinworms 3]pin worms detected by parents and captured on photos or videos stamped with date, time and place(geo tagged).
排除标准
- •All the children who already took any of three drugs under study within the past three months.
结局指标
主要结局
occurrence of remission in each of the arm by remission score
时间窗: 0 to 8 weeks after initiation of treatment
次要结局
- occurrence of recurrence in each of the arm(1 to 3 months of remission)
研究者
Annaswamy V Renuka Devi
vinayaka missions medical college and hospital