Management of Soil-transmitted Helminthiasis and Strongyloidiasis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01308268

Enrollment

2000

Registered

2011-03-04

Start date

2010-12-31

Completion date

2012-04-30

Last updated

2011-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helminthiasis, Strongyloides Stercoralis Infection

Keywords

STH, Soil-transmitted Helminthiasis, mass drug administration

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.

Interventions

DRUGIvermectin + Albendazole

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy	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

Measure	Time frame	Description
Validate serology methods for diagnosis of S. stercoralis infection	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	15 months	—

Countries

Argentina

Contacts

Primary ContactAlejandro Krolewiecki, MD, PhD

alekrol@hotmail.com+54-11-45531369

Backup ContactMaría E Socías, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026