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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 13, 2005 | ||||||||
| Last Updated Date | November 16, 2005 | ||||||||
| Start Date ICMJE | February 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00207753 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
ectoparasite examination | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections | ||||||||
| Official Title ICMJE | Efficacy and Nutritional Assessment Following Albendazole and Combined Albendazole/Ivermectin Treatment for Intestinal Helminth Infections in Rural Guatemalan Schoolchildren | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: albendazole vs. combined albendazole/ivermectin treatment | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 550 | ||||||||
| Completion Date | March 2005 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||||||
| Ages | 5 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Guatemala | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00207753 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDC-NCID-4283 | ||||||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||||||
| Collaborators ICMJE | Universidad del Valle, Guatemala | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||||||
| Verification Date | September 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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