Efficacy and safety of of tribendimidine against hookworm infections in children: a randomized controlled trial

Phase 2

Completed

• Conditions: Hookworm infection; Infections and Infestations

• Registration Number: ISRCTN81391471
• Lead Sponsor: Swiss Tropical and Public Health Institute

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30496350 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29914958

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: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Written informed consent signed by parents and/or legal representative; and oral assent by child
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. Positive for hookworm eggs in the stool
5. Absence of major systemic illnesses, e.g. diabetes, severe anemia, clinical malaria as assessed by a medical doctor, upon initial clinical assessment
6. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease
7. No recent anthelminthic treatment (within past 4 weeks)
8. No known allergy to tribendimidine
9. Age range is 6-12 years old

Exclusion Criteria

1. No written informed consent by parents and/or legal representative
2. Presence of major systemic illnesses, e.g. diabetes, 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 hookworm eggs in the stool

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate (conversion from being egg positive pre-treatment to egg negative post-treatment) against hookworm 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 against hookworm infection will be assessed using the quadruple Kato-Katz method at 21 days post-treatment<br> 2. Cure and egg reduction rate against concomitant soil-transmitted helminths 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 and 24 hours after treatment<br> 4. Pharmacokinetic parameters: drug concentrations will be measured with a validated LC/MS method at baseline, 2, 3, 4, 5, 6, 7, 7.5, 8.5 and 24 hours post-dosing<br>