An interventional study of albendazole vs. combined albendazole/ivermectin treatment in Ascariasis, Trichuriasis and Hookworm Infection, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in Guatemala. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-11-17.
Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 550 is above the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
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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
efficacy against geohelminths (stool egg count)
height increase
weight increase
ectoparasite examination
The record gives a start of Feb 2005 and a completion of Mar 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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