Management of Soil-transmitted Helminthiasis and Strongyloidiasis

Study Overview
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Brief Summary
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The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a highly endemic area in northern Argentina with a multidisciplinary approach. The specific objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration regimen with albendazole and ivermectin.

Official Title
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Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area

Conditions
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Helminthiasis, Strongyloides Stercoralis Infection

Intervention / Treatment
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* Drug: Ivermectin + Albendazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All persons that are living in the working area at the time of the intervention and wish to participate in the study. Exclusion Criteria: All persons that live within the study area but do not want to participate in the study. Pregnant women or women who are likely pregnant. Women during the first post-partum week if they are breastfeeding. Children who weigh less than 15 kg. Persons with a history of hypersensitivity or intolerance to ivermectin, albendazole or to the components that make up those drugs.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ivermectin + Albendazole|Ivermectin: 200µg/kg, single dose, PO + Albendazole 200 (children between 12 and 23 months) or 400 mg (>= 2 years old) single dose, PO|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy | Evaluate local epidemiology of STH: frequency of species, prevalence and intensity of infections, groups more affected, morbidity. Evaluate the efficacy of a single-dose anti-helminthic regimen for community treatments: albendazole 400 mg + ivermectin 200 mcg/kg. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate serology methods for diagnosis of S. stercoralis infection | Compare sensibility, specificity and predictive values of serology for S.stercoralis (ELISA-NIE) with traditional coproparasitological methods | 15 months | 
| Assess the tolerability and safety of the combination of ivermectin and albendazole |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STH, Soil-transmitted Helminthiasis, mass drug administration