Management of Soil-transmitted Helminthiasis and Strongyloidiasis

Not Applicable

• Conditions: Helminthiasis; Strongyloides Stercoralis Infection

• Registration Number: NCT01308268
• Lead Sponsor: Universidad Nacional de Salta

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Status Verified: 2011-02
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Last Update Submitted: 2011-03-03
• Study First Posted: 2011-03-04
• Last Update Posted: 2011-03-04
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

1. All persons that live within the study area but do not want to participate in the study.
2. Pregnant women or women who are likely pregnant.
3. Women during the first post-partum week if they are breastfeeding.
4. Children who weigh less than 15 kg.
5. Persons with a history of hypersensitivity or intolerance to ivermectin, albendazole or to the components that make up those drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy	15 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta; 🇦🇷 Orán, Salta, Argentina