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Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections

Primary Purpose

Ascariasis, Trichuriasis, Hookworm Infection

Status
Completed
Phase
Not Applicable
Locations
Guatemala
Study Type
Interventional
Intervention
albendazole vs. combined albendazole/ivermectin treatment
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascariasis focused on measuring ascaris, trichuris, strongyloides, hookworm, head lice

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Various elementary schools

Outcomes

Primary Outcome Measures

efficacy against geohelminths (stool egg count)
height increase
weight increase

Secondary Outcome Measures

ectoparasite examination

Full Information

First Posted
September 13, 2005
Last Updated
November 16, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
Universidad del Valle, Guatemala
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1. Study Identification

Unique Protocol Identification Number
NCT00207753
Brief Title
Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections
Official Title
Efficacy and Nutritional Assessment Following Albendazole and Combined Albendazole/Ivermectin Treatment for Intestinal Helminth Infections in Rural Guatemalan Schoolchildren
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Universidad del Valle, Guatemala

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascariasis, Trichuriasis, Hookworm Infection, Strongyloidiasis, Pediculosis
Keywords
ascaris, trichuris, strongyloides, hookworm, head lice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
550 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
albendazole vs. combined albendazole/ivermectin treatment
Primary Outcome Measure Information:
Title
efficacy against geohelminths (stool egg count)
Title
height increase
Title
weight increase
Secondary Outcome Measure Information:
Title
ectoparasite examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Beach, Ph.D.
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byron Arana, MD
Organizational Affiliation
MERTU/CDC-Universite de Valle de Guatemala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Various elementary schools
City
Poptun
State/Province
Peten
Country
Guatemala

12. IPD Sharing Statement

Citations:
PubMed Identifier
11386691
Citation
Stephenson LS, Latham MC, Ottesen EA. Global malnutrition. Parasitology. 2000;121 Suppl:S5-22. doi: 10.1017/s0031182000006478.
Results Reference
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PubMed Identifier
11386688
Citation
Stephenson LS, Latham MC, Ottesen EA. Malnutrition and parasitic helminth infections. Parasitology. 2000;121 Suppl:S23-38. doi: 10.1017/s0031182000006491.
Results Reference
background
PubMed Identifier
11386686
Citation
Horton J, Witt C, Ottesen EA, Lazdins JK, Addiss DG, Awadzi K, Beach MJ, Belizario VY, Dunyo SK, Espinel M, Gyapong JO, Hossain M, Ismail MM, Jayakody RL, Lammie PJ, Makunde W, Richard-Lenoble D, Selve B, Shenoy RK, Simonsen PE, Wamae CN, Weerasooriya MV. An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis. Parasitology. 2000;121 Suppl:S147-60. doi: 10.1017/s0031182000007423.
Results Reference
background
Citation
World Health Organization, 1992. Health of school children: treatment of intestinal helminths and schistosomiasis. Geneva: WHO.
Results Reference
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Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections

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