Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ascariasis; Trichuriasis; Hookworm Infection; Strongyloidiasis; Pediculosis
Intervention: albendazole vs. combined albendazole/ivermectin treatment (Drug)
Phase: N/A
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s): Michael J Beach, Ph.D., Principal Investigator, Affiliation: Centers for Disease Control and Prevention Byron Arana, MD, Principal Investigator, Affiliation: MERTU/CDC-Universite de Valle de Guatemala
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.
Clinical Details
Official title: Efficacy and Nutritional Assessment Following Albendazole and Combined Albendazole/Ivermectin Treatment for Intestinal Helminth Infections in Rural Guatemalan Schoolchildren
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: efficacy against geohelminths (stool egg count)height increase weight increase
Secondary outcome: ectoparasite examination
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
Minimum age: 5 Years.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
Various elementary schools, Poptun, Peten, Guatemala
Additional Information
Related publications: Stephenson LS, Latham MC, Ottesen EA. Global malnutrition. Parasitology. 2000;121 Suppl:S5-22. Review. Stephenson LS, Latham MC, Ottesen EA. Malnutrition and parasitic helminth infections. Parasitology. 2000;121 Suppl:S23-38. Review. 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. Review. World Health Organization, 1992. Health of school children: treatment of intestinal helminths and schistosomiasis. Geneva: WHO.
Starting date: February 2005
Last updated: November 16, 2005
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