Efficacy and Safety of Moxidectin-albendazole Combination for Trichuris Trichiura Infections in School-aged Children: a Double-blind Randomised Controlled Superiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Cure Rate (CR) Against T. Trichiura
研究概览
简要总结
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
详细描述
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among SAC receiving moxidectin/albendazole combination therapy and albendazole monotherapy.
The secondary objectives of the trial are to compare the egg reduction rates (ERRs) of the treatment regimens against T. trichiura, to determine the CRs and ERRs of the drugs in study participants co-infected with A. lumbricoides and hookworm, and to evaluate the safety and tolerability of the treatment regimens.
In addition, this study aims to characterize population pharmacokinetics of moxidectin in T. trichiura infected SAC.
After obtaining informed consent from parents and/or caregivers, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples, which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians.
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)
盲法说明
The trial will be double blinded (i.e. study participants and the trial team/researchers conducting the treatment and assessing the outcomes will be blinded) using appearance-matching placebos.
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
- •individuals aged 6-12 years (confirmed by birth certificate or similar document)
- •having given written informed consent signed by parents/caregivers
- •being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
- •having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
- •being able and willing to be examined by a study physician before and after treatment
排除标准
- •presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <80 g/l)
- •history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
- •use of anthelminthic drugs during study period
- •known allergy to study medication (i.e., moxidectin or albendazole)
- •being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
- •pregnancy (female participants aged 10-12 years)
- •concurrent participation in other clinical trials
研究组 & 干预措施
Arm A: Moxidectin 4/8 mg & Albendazole
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
干预措施: Moxidectin 2 mg Oral Tablet (Drug)
Arm A: Moxidectin 4/8 mg & Albendazole
Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
干预措施: Albendazole 400 mg Oral Tablet (Drug)
Arm B: Albendazole
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
干预措施: Albendazole 400 mg Oral Tablet (Drug)
Arm B: Albendazole
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
干预措施: Placebo Moxidectin (Drug)
Arm C: Placebo
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
干预措施: Placebo Moxidectin (Drug)
Arm C: Placebo
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
干预措施: Placebo Albendazole (Drug)
结局指标
主要结局
Cure Rate (CR) Against T. Trichiura
时间窗: 14-21 days post-treatment
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
次要结局
- Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)(14-21 days post-treatment)
- Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)(14-21 days post-treatment)
- Cure Rate (CR) Against A. Lumbricoides(14-21 days post-treatment)
- Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)(14-21 days post-treatment)
- Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)(14-21 days post-treatment)
- Cure Rate (CR) Against Hookworm(14-21 days post-treatment)
- Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR)(14-21 days post-treatment)
- Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR)(14-21 days post-treatment)
- Number of Participants Reporting Adverse Events (AEs)(3 hours, 24 hours and 14-21 days post-treatment)
研究者
Jennifer Keiser
Prof. Dr.
Swiss Tropical & Public Health Institute