Management of Soil-transmitted Helminthiasis and Strongyloidiasis

Helminthiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01308268
• Other study ID #: IIET-05
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2011
• Last updated: March 3, 2011
• Start date: December 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2011
• Source: Universidad Nacional de Salta
• Contact: Alejandro Krolewiecki, MD, PhD
• Phone: +54-11-45531369
• Email: alekrol[@]hotmail.com
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helminthiasis
• Strongyloides Stercoralis Infection
• Strongyloidiasis

Intervention

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

Locations

Country	Name	City	State
Argentina	Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta	Orán	Salta

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Nacional de Salta	Albert B. Sabin Vaccine Institute, Fundación Mundo Sano

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Assess the tolerability and safety of the combination of ivermectin and albendazole		15 months	Yes