Evaluating the efficacy of different tribendimidine combinations against intestinal worms (soil-transmitted helminths)

Not Applicable

Completed

• Conditions: Hookworm infection; Infections and Infestations

• Registration Number: ISRCTN14373201
• Lead Sponsor: Swiss Tropical and Public Health Institute

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28864027 results 2018 Other publications in https://pubmed.ncbi.nlm.nih.gov/29864132/ diagnostic comparison conducted in the framework of the clinical trial based exclusively on samples collected in Tanzania (added 30/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-19
• Study Completion: 2017-05-01
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

1. Written informed consent signed by parents and/or legal guardian; and assent by children
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, anemia) 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 study medications (e.g. albendazole, mebendazole)
9. Aged 15-18 years

Exclusion Criteria

1. No written informed consent by parents and/or legal guardian and assent for children
2. Presence of major systemic illnesses (e.g. diabetes, anemia) 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
Egg-reduction rates against hookworm are measured calculating the mean reduction in egg-counts at follow-up (after 14-21 days) compared to baseline (based on quadruplicated Kato-Katz thick smears).

Secondary Outcome Measures

Name	Time	Method
1. Cure rate (CR) against hookworm is the percentage of children egg negative calculated at follow-up (14-21 days post treatment) based on a quadruplicated Kato-Katz thick smear<br>2. Cure rate (CR) and egg-reduction rate (ERR) against A. lumbricoides and T. trichiura are egg free children at follow-up (14-21 days post treatment based on a quadruplicated Kato-Katz thick smear) or the mean reduction in egg-counts at follow-up (after 14-21 days) compared to baseline (based on quadruplicated Kato-Katz thick smear)<br>3. Pharmacokinetic parameters are determined based on concentration of the different drugs measured<br>4. Safety is measured based on number of children reporting adverse events at the time points 3 and 24 hours post treatment using a standardized questionnaire