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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborators:
Fundación Mundo Sano
Albert B. Sabin Vaccine Institute
Information provided by:
Universidad Nacional de Salta

Tracking Information
First Submitted Date  ICMJE March 3, 2011
First Posted Date  ICMJE March 4, 2011
Last Update Posted Date March 4, 2011
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Soil-transmitted Helminthiasis and Strongyloidiasis
Official Title  ICMJE Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Helminthiasis
  • Strongyloides Stercoralis Infection
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 3, 2011)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2012
Estimated Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01308268
Other Study ID Numbers  ICMJE IIET-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alejandro Krolewiecki, Instituto de Investigaciones en Enfermedades Tropicales-Universidad Nacional de Salta
Study Sponsor  ICMJE Universidad Nacional de Salta
Collaborators  ICMJE
  • Fundación Mundo Sano
  • Albert B. Sabin Vaccine Institute
Investigators  ICMJE
Principal Investigator: Alejandro Krolewiecki, MD, PhD Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales
PRS Account Universidad Nacional de Salta
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP