CompletedNot Applicable

Monitoring Drug Efficacy and Anthelmintic Resistance in Soil-transmitted Helminth Programs

Bangladesh, Cambodia, Ghana9,457 participantsStarted 2019-05-15

Plain-language summary

Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem. The overall aim of this study is to pilot a surveillance system to assess anthelmintic drug efficacy and the emergence of AR in 9 countries were drug pressure has been high over a long period of time. The specific objectives are to: 1. Assess the prevalence of moderate/heavy intensity infections of the different STH 2. Assess the drug efficacy of a single dose of BZ drugs against STH infections in these countries 3. Assess the frequency of the ß-tubulin SNPs linked to BZ resistance 4. Identify implementation-related barriers and opportunities for monitoring drug efficacy and AR in national PC programs for STH. 5. Expand the Starworms repository of STH field samples

Who can participate

Age range

5 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject, male or female, is 5-14 years of age * Subject is otherwise in healthy condition (based on medical history and physical examination) * Parent(s)/guardians of subject signed an informed consent document indicating that they understand the purpose of and procedures required for the study and that they are willing to have their child participate in the study * Subject of ≥6 years has assented to participate in the study * Subject of ≥12 years has signed an informed consent document indicating that they understand the purpose of the study and procedures required for the study and are willing to participate in the study * Subject has provided a stool sample of at least 5 grams. Exclusion Criteria: * Subject has active diarrhoea (defined as the passage of 3 or more loose or liquid stools per day) at baseline or follow-up. * Subject has an acute medical condition or is experiencing a severe concurrent medical condition * Subject has a known hypersensitivity to ALB or MEB * Subject has received anthelmintic treatment within 90 days prior to the start of the treatment * Subject vomited within 4 hours following drug ingestion. * Subject is not able to provide a stool sample of minimum 5 grams at baseline or follow-up. * Subject has not swallowed the entire tablet.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

moderate/heavy intensity infections of the different STH

Timeframe: up to 12 months

drug efficacy of a single dose of BZ drugs against STH infections in these countries

Timeframe: up to 12 months

frequency of the ß-tubulin SNPs linked to BZ resistance

Timeframe: up to 12 months

Trial details

NCT IDNCT04177654

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Soil-transmitted Helminth Infections trials

Plain-language summary

Who can participate

Age range

5 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.