Clinical trial NCT00207753: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ascariasis
Trichuriasis
Hookworm Infection
Strongyloidiasis
Pediculosis
Keywords: ascaris
trichuris
strongyloides
hookworm
head lice
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Universidad del Valle, Guatemala
First posted: 2005-09-21
Enrollment: 550
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: efficacy against geohelminths (stool egg count)
measure: height increase
measure: weight increase
Secondary outcomes:
measure: ectoparasite examination
Other outcomes:
Locations:
city: Poptun
country: Guatemala
facility: Various elementary schools
state: Peten
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Michael J Beach, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: MERTU/CDC-Universite de Valle de Guatemala
name: Byron Arana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stephenson LS, Latham MC, Ottesen EA. Global malnutrition. Parasitology. 2000;121 Suppl:S5-22. doi: 10.1017/s0031182000006478.
citation: Stephenson LS, Latham MC, Ottesen EA. Malnutrition and parasitic helminth infections. Parasitology. 2000;121 Suppl:S23-38. doi: 10.1017/s0031182000006491.
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.
citation: World Health Organization, 1992. Health of school children: treatment of intestinal helminths and schistosomiasis. Geneva: WHO.