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Management of Soil-transmitted Helminthiasis and Strongyloidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01308268
Recruitment Status : Unknown
Verified February 2011 by Universidad Nacional de Salta.
Recruitment status was:  Recruiting
First Posted : March 4, 2011
Last Update Posted : March 4, 2011
Fundación Mundo Sano
Albert B. Sabin Vaccine Institute
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Helminthiasis Strongyloides Stercoralis Infection Drug: Ivermectin + Albendazole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area
Study Start Date : December 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. Assess the tolerability and safety of the combination of ivermectin and albendazole [ Time Frame: 15 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01308268

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Contact: Alejandro Krolewiecki, MD, PhD +54-11-45531369
Contact: María E Socías, MD +54-11-4803-2298

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Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta Recruiting
Orán, Salta, Argentina, 4530
Sponsors and Collaborators
Universidad Nacional de Salta
Fundación Mundo Sano
Albert B. Sabin Vaccine Institute
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Principal Investigator: Alejandro Krolewiecki, MD, PhD Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales

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Responsible Party: Alejandro Krolewiecki, Instituto de Investigaciones en Enfermedades Tropicales-Universidad Nacional de Salta Identifier: NCT01308268    
Other Study ID Numbers: IIET-05
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: February 2011
Keywords provided by Universidad Nacional de Salta:
Soil-transmitted Helminthiasis
mass drug administration
Additional relevant MeSH terms:
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Parasitic Diseases
Rhabditida Infections
Secernentea Infections
Nematode Infections
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents