Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections

This study has been completed.
Sponsor:
Collaborator:
Universidad del Valle, Guatemala
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207753
First received: September 13, 2005
Last updated: November 16, 2005
Last verified: September 2005
  Purpose

The aim of this study is to compare the efficacy and impact on growth of two drug treatments against intestinal worms in schoolchildren from a rural area of Guatemala. According to the World Bank, these intestinal worms are one of the top causes of childhood health problems in many areas of the developing world (The World Bank, 1993). Infected children are more likely to have inadequate nutrition due to the worm infections and are more likely to be shorter in height and weigh less than children who are not infected. After collecting height and weight information, we will split the children into two groups. One group will receive albendazole and the other group will receive combined albendazole/ivermectin. Both groups will be receiving albendazole, the current standard of care treatment. Ivermection is expected to improve efficacy and nutritional benefit as well as add increased scope of treatment for the worm Strongyloides, and ectoparasites such as scabies and head lice. Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs would be a more efficient use of the opportunity to access schoolchildren and provide deworming treatment.


Condition Intervention
Ascariasis
Trichuriasis
Hookworm Infection
Strongyloidiasis
Pediculosis
Drug: albendazole vs. combined albendazole/ivermectin treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Nutritional Assessment Following Albendazole and Combined Albendazole/Ivermectin Treatment for Intestinal Helminth Infections in Rural Guatemalan Schoolchildren

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • efficacy against geohelminths (stool egg count)
  • height increase
  • weight increase

Secondary Outcome Measures:
  • ectoparasite examination

Estimated Enrollment: 550
Study Start Date: February 2005
Estimated Study Completion Date: March 2005
Detailed Description:

The aim of this study is to compare the efficacy and nutritional impact of two drug treatments against intestinal helminths from a rural area of Guatemala. The helminths that will be analyzed in this study are Ascaris lumbricoides, Trichuris trichiura, and hookworm. Because of the manifestations of these helminths infections, nutritional status can deteriorate in infected persons. According to the World Bank, these helminths are one of the top causes of childhood morbidity in many areas of the developing world (The World Bank, 1993).

This information will be gathered by collecting stool samples from schoolchildren, in order to determine the prevalence of infection in children living around Poptun, Guatemala. Height and weight measurements will also be taken, along with a visual exam of the skin for other parasitic skin infections. Children with an inadequate nutritional status are likely to be shorter in height and weigh less than children reared in an area with a low prevalence of helminths. After collecting this baseline information, we will split the children into two groups. One group will receive albendazole and the other group will receive albendazole/ivermectin. Both groups will be receiving is albendazole, the current standard of care treatment. Ivermectin is expected to improve efficacy and nutritional benefit as well as adding increased scope of treatment (Strongyloides, ectoparasites such as scabies and head lice). Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs is thought to be a more efficient use of the opportunity to access schoolchildren and provide health improvements. Providing data to support expanded treatment options will provide public health officials with the data needed to make such decisions.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Children will be eligible to participate in the study if they are between 5 and 12 years of age, are students in schools selected for study, and if parental consent and child assent for participation has been obtained.

Exclusion Criteria:

those not fitting criteria above

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207753

Locations
Guatemala
Various elementary schools
Poptun, Peten, Guatemala
Sponsors and Collaborators
Universidad del Valle, Guatemala
Investigators
Principal Investigator: Michael J Beach, Ph.D. Centers for Disease Control and Prevention
Principal Investigator: Byron Arana, MD MERTU/CDC-Universite de Valle de Guatemala
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00207753     History of Changes
Other Study ID Numbers: CDC-NCID-4283
Study First Received: September 13, 2005
Last Updated: November 16, 2005
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
ascaris
trichuris
strongyloides
hookworm
head lice

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hookworm Infections
Ancylostomiasis
Strongyloidiasis
Ascariasis
Trichuriasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Rhabditida Infections
Ascaridida Infections
Enoplida Infections
Adenophorea Infections
Albendazole
Ivermectin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014