Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207753
Status:
COMPLETED
Last Update Posted:
2005-11-17
First Post:
2005-09-13
Brief Title:
Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Efficacy and Nutritional Assessment Following Albendazole and Combined AlbendazoleIvermectin Treatment for Intestinal Helminth Infections in Rural Guatemalan Schoolchildren
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 albendazoleivermectin 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 albendazoleivermectin 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
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 albendazoleivermectin 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None