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Management of Soil-transmitted Helminthiasis and Strongyloidiasis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Universidad Nacional de Salta.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308268
First Posted: March 4, 2011
Last Update Posted: March 4, 2011
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.
Collaborators:
Fundación Mundo Sano
Albert B. Sabin Vaccine Institute
Information provided by:
Universidad Nacional de Salta
  Purpose
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 Intervention
Helminthiasis Strongyloides Stercoralis Infection Drug: Ivermectin + Albendazole

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universidad Nacional de Salta:

Primary Outcome Measures:
  • 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:
  • 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

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

Estimated Enrollment: 2000
Study Start Date: December 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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

  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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01308268


Contacts
Contact: Alejandro Krolewiecki, MD, PhD +54-11-45531369 alekrol@hotmail.com
Contact: María E Socías, MD +54-11-4803-2298 eugenia_socias@yahoo.com.ar

Locations
Argentina
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
Investigators
Principal Investigator: Alejandro Krolewiecki, MD, PhD Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales
  More Information

Responsible Party: Alejandro Krolewiecki, Instituto de Investigaciones en Enfermedades Tropicales-Universidad Nacional de Salta
ClinicalTrials.gov Identifier: NCT01308268     History of Changes
Other Study ID Numbers: IIET-05
First Submitted: March 3, 2011
First Posted: March 4, 2011
Last Update Posted: March 4, 2011
Last Verified: February 2011

Keywords provided by Universidad Nacional de Salta:
STH
Soil-transmitted Helminthiasis
mass drug administration

Additional relevant MeSH terms:
Helminthiasis
Strongyloidiasis
Parasitic Diseases
Rhabditida Infections
Secernentea Infections
Nematode Infections
Albendazole
Ivermectin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents