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Management of Soil-transmitted Helminthiasis and Strongyloidiasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Universidad Nacional de Salta.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fundación Mundo Sano
Albert B. Sabin Vaccine Institute
Information provided by:
Universidad Nacional de Salta
ClinicalTrials.gov Identifier:
NCT01308268
First received: March 3, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 3, 2011
Last Updated: March 3, 2011
Health Authority: Argentina: Human Research Bioethics Committee

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
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013