Management of Soil-transmitted Helminthiasis and Strongyloidiasis

NCT01308268 | Unknown

• 1 other identifier: IIET-05
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Helminthiasis; Strongyloides Stercoralis Infection

Keywords

STH; Soil-transmitted Helminthiasis; mass drug administration

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Validate serology methods for diagnosis of S. stercoralis infection

  15 months

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

  15 months

Interventions

Ivermectin + Albendazole DRUG

Ivermectin: 200µg/kg, single dose, PO + Albendazole 200 (children between 12 and 23 months) or 400 mg (\>= 2 years old) single dose, PO

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All persons that are living in the working area at the time of the intervention and wish to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Salta: lead
• Fundación Mundo Sano: collaborator
• Albert B. Sabin Vaccine Institute: collaborator

Study Sites (1)

Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta

Orán, Salta Province, 4530, Argentina

RECRUITING

MeSH Terms

Conditions

Helminthiasis

Interventions

Ivermectin; Albendazole

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alejandro Krolewiecki, MD, PhD

  Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Krolewiecki, MD, PhD

CONTACT

+54-11-45531369; alekrol@hotmail.com

María E Socías, MD

CONTACT

+54-11-4803-2298; eugenia_socias@yahoo.com.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 4, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 4, 2011

Record last verified: 2011-02

Locations

AR (1)