Management of Soil-transmitted Helminthiasis and Strongyloidiasis

March 3, 2011 updated by: Universidad Nacional de Salta

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Salta
      • Orán, Salta, Argentina, 4530
        • Recruiting
        • Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

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
Time Frame: 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.
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate serology methods for diagnosis of S. stercoralis infection
Time Frame: 15 months
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
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Salta

Collaborators

Albert B. Sabin Vaccine Institute
Fundación Mundo Sano

Investigators

  • Principal Investigator: Alejandro Krolewiecki, MD, PhD, Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2012

Study Completion (ANTICIPATED)

April 1, 2012

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (ESTIMATE)

March 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIET-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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