Efficacy and safety of ascending dosages of ivermectin against Trichuris trichiura in preschool- and school-aged children: a randomized controlled trial

Swiss Tropical and Public Health Institute0 个研究点目标入组 290 人开始时间: 2017年5月19日最近更新: 2019年4月1日

适应症

试验速览

2018 efficacy and safety results in: https://www.ncbi.nlm.nih.gov/pubmed/29617737 2. 2019 pharmacokinetics results in https://www.ncbi.nlm.nih.gov/pubmed/30859185 (added 13/03/2019)

•1. Written informed consent signed by either participating PK patient or for the study involving children parents and/or caregiver; and oral assent by child (aged 6-12 years)
•2. Able and willing to be examined by a study physician at the beginning of the study
•3. Able and willing to provide two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up)
•4. Corresponding age to be included in the respective age groups of interest (i.e. between 2 to 5 years for preschoolers, between 6 to 12 for school-aged children or =21 years for the adult age group sample)
•5. Positive for T. trichiura eggs in the stool
•6. Absence of major systemic illnesses, e.g. severe anemia, clinical malaria as assessed by a medical doctor, upon initial clinical assessment
•7. No known or reported history of chronic illness as cancer, diabetes, chronic heart, liver or renal disease
•8. No recent anthelminthic treatment (within past 4 weeks)
•9. No known allergy to study medications (i.e., ivermectin)

•1. No written informed consent by individual/parents and/or caregiver
•2. Presence of major systemic illnesses, e.g. severe anemia, clinical malaria as assessed by a medical doctor, upon initial clinical assessment
•3. History of acute or severe chronic disease
•4. Recent use of anthelminthic drug (within past 4 weeks)
•5. Attending other clinical trials during the study
•6. Negative diagnostic result for T. trichiura eggs in the stool

发起方

Swiss Tropical and Public Health Institute