Efficacy and safety of ivermectin against Trichuris trichiura

Phase 2

Completed

• Conditions: Trichuris infection; Infections and Infestations

• Registration Number: ISRCTN15871729
• Lead Sponsor: Swiss Tropical and Public Health Institute

Brief Summary

1. 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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-19
• Study Completion: 2017-12-31
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate (CR) (conversion from being egg positive pre-treatment to egg negative post-treatment) for Trichuris infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Egg reduction rate for Trichuris infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment<br> 2. Cure rate and egg reduction rate for concomitant soil-transmitted helminth infections will be assessed using the quadruple Kato-Katz method at 21 days post-treatment<br> 3. Safety will be assessed with evaluation of adverse events of the treated subjects based on interviews at 3, 24, and 72 hours after treatment<br> 4. Pharmacokinetic parameters: drug concentrations will be measured with a validated LC/MS method at baseline, 2, 4, 6, 7, 8, 9, 24, 48 and 72 hours post treatment<br>