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Management of Soil-transmitted Helminthiasis and Strongyloidiasis

Primary Purpose

Helminthiasis, Strongyloides Stercoralis Infection

Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Ivermectin + Albendazole
Sponsored by
Universidad Nacional de Salta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helminthiasis focused on measuring STH, Soil-transmitted Helminthiasis, mass drug administration

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de SaltaRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Assess the tolerability and safety of the combination of ivermectin and albendazole

Full Information

First Posted
March 3, 2011
Last Updated
March 3, 2011
Sponsor
Universidad Nacional de Salta
Collaborators
Fundación Mundo Sano, Albert B. Sabin Vaccine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01308268
Brief Title
Management of Soil-transmitted Helminthiasis and Strongyloidiasis
Official Title
Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Nacional de Salta
Collaborators
Fundación Mundo Sano, Albert B. Sabin Vaccine Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helminthiasis, Strongyloides Stercoralis Infection
Keywords
STH, Soil-transmitted Helminthiasis, mass drug administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ivermectin + Albendazole
Intervention Description
Ivermectin: 200µg/kg, single dose, PO + Albendazole 200 (children between 12 and 23 months) or 400 mg (>= 2 years old) single dose, PO
Primary Outcome Measure Information:
Title
Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy
Description
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.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Validate serology methods for diagnosis of S. stercoralis infection
Description
Compare sensibility, specificity and predictive values of serology for S.stercoralis (ELISA-NIE) with traditional coproparasitological methods
Time Frame
15 months
Title
Assess the tolerability and safety of the combination of ivermectin and albendazole
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Krolewiecki, MD, PhD
Phone
+54-11-45531369
Email
alekrol@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
María E Socías, MD
Phone
+54-11-4803-2298
Email
eugenia_socias@yahoo.com.ar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Krolewiecki, MD, PhD
Organizational Affiliation
Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta
City
Orán
State/Province
Salta
ZIP/Postal Code
4530
Country
Argentina
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Management of Soil-transmitted Helminthiasis and Strongyloidiasis

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