Efficacy of the Combination Ivermectin and Albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)
研究概览
简要总结
The goal of this parallel open-label randomized controlled superiority trial is to demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of cure rates against Trichuris trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years.
The main questions it aims to answer are:
- Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against T. trichiura infections in children aged 6-12 years in Uganda?
- Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against co-infecting soil-transmitted helminth infections such as Ascaris lumbricoides and hookworm in children aged 6-12 years in Uganda?
- Is single oral dose combined ivermectin-albendazole as tolerable and safe as albendazole monotherapy in children aged 6-12 years in Uganda?
Participants will be asked to provide two stool samples at baseline that will be subjected to microscopic analysis using the Kato-Katz thick smear technique for detection of soil-transmitted helminth eggs. T. trichiura-infected participants will be:
- clinically examined for general health, anthropometric parameters including height and weight as well as temperature
- randomly assigned to either receive one single oral dose of combined ivermectin and albendazole or albendazole monotherapy
- checked for any potential adverse events and will undergo a brief questionnaire on specific symptoms 3h after drug administration
- asked to provide another two stool samples to be microscopically examined for helminth eggs 14-21 days post-treatment Researchers will compare individuals treated with ivermectin-albendazole and albendazole alone to see if the proportion of T. trichiura egg-negative individuals and/or reduction in egg counts differs between these two groups 14-21 days after treatment.
详细描述
In view that efficacy of co-administered ivermectin (IVM) and albendazole (ALB) has been found to vary between different settings the rationale of this parallel open-label randomized controlled superiority trial is to provide evidence on the efficacy of co-administered ivermectin and albendazole compared to albendazole monotherapy in school-aged children aged 6-12 years against infection with T. trichiura in Uganda.
Our primary objective is to demonstrate superiority of
- Arm A: single dose of ivermectin (200 µg/kg, 3 mg tablets according to weight) / single dose of albendazole (400 mg tablet) combination, compared to
- Arm B: single dose of albendazole (400 mg tablet)
in terms of cure rate (CR) against T. trichiura infections in school-aged children aged 6-12 years assessed at 14-21 days post-treatment by Kato-Katz microscopy.
The secondary objectives of the trial are:
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 (Outcomes Assessor)
盲法说明
Allocation concealment will be warranted using sequential, opaque, sealed envelopes. Outcome assessors in the lab will be blinded.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent for participation signed from caregivers; and written assent by participants.
- •Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and at follow-up assessment 14-21 days after treatment.
- •Willing to be examined by a study nurse/physician prior to treatment.
- •At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura.
排除标准
- •Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, clinical malaria (fever + positive RDT) upon initial clinical assessment.
- •Recent use of anthelmintic drug (within past 4 weeks).
- •Attending other experimental research studies.
- •Known allergy to study medications (i.e. benzimidazole or ivermectin).
研究组 & 干预措施
ALB (400mg)
A single tablet of albendazole (400mg), provided as single oral dose.
干预措施: ALB (400mg) (Drug)
IVM (200 µg/kg) + ALB (400 mg)
A single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose.
干预措施: IVM (200 µg/kg) + ALB (400 mg) (Drug)
结局指标
主要结局
Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)
时间窗: 14-21 days after treatment
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
次要结局
- Egg Reduction Rate (ERR) against T. Trichiura(14-21 days after treatment)
- Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)(14-21 days after treatment)
- Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections(14-21 days after treatment)
研究者
Jennifer Keiser
Prof. Dr.
Swiss Tropical & Public Health Institute