Management of Soil-transmitted Helminthiasis and Strongyloidiasis

NCT ID: NCT01308268

Last Updated: 2011-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-04-30

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.

Detailed Description

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Conditions

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Helminthiasis Strongyloides Stercoralis Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

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

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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Mundo Sano

UNKNOWN

Sponsor Role collaborator

Albert B. Sabin Vaccine Institute

OTHER

Sponsor Role collaborator

Universidad Nacional de Salta

OTHER

Sponsor Role lead

Responsible Party

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Instituto de Investigaciones en Enfermedades Tropicales-Universidad Nacional de Salta

Principal Investigators

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Alejandro Krolewiecki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales

Locations

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Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta

Orán, Salta Province, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Alejandro Krolewiecki, MD, PhD

Role: CONTACT

+54-11-45531369

María E Socías, MD

Role: CONTACT

+54-11-4803-2298

Other Identifiers

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IIET-05

Identifier Type: -

Identifier Source: org_study_id

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