Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections

NCT00207753 | Completed

• 1 other identifier: CDC-NCID-4283
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Ascariasis; Trichuriasis; Hookworm Infection; Strongyloidiasis; Pediculosis

Keywords

ascaris; trichuris; strongyloides; hookworm; head lice

Outcome Measures

Primary Outcomes (3)

• efficacy against geohelminths (stool egg count)

• height increase

• weight increase

Secondary Outcomes (1)

• ectoparasite examination

Interventions

albendazole vs. combined albendazole/ivermectin treatment DRUG

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• those not fitting criteria above

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Universidad del Valle, Guatemala: collaborator

Study Sites (1)

Various elementary schools

Poptún, Departamento del Petén, Guatemala

Location

Related Publications (4)

• Stephenson LS, Latham MC, Ottesen EA. Global malnutrition. Parasitology. 2000;121 Suppl:S5-22. doi: 10.1017/s0031182000006478.

  PMID: 11386691 BACKGROUND

• Stephenson LS, Latham MC, Ottesen EA. Malnutrition and parasitic helminth infections. Parasitology. 2000;121 Suppl:S23-38. doi: 10.1017/s0031182000006491.

  PMID: 11386688 BACKGROUND

• 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.

  PMID: 11386686 BACKGROUND

• World Health Organization, 1992. Health of school children: treatment of intestinal helminths and schistosomiasis. Geneva: WHO.

  BACKGROUND

MeSH Terms

Conditions

Ascariasis; Trichuriasis; Hookworm Infections; Strongyloidiasis; Lice Infestations; Ancylostomiasis

Condition Hierarchy (Ancestors)

Ascaridida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Enoplida Infections; Adenophorea Infections; Strongylida Infections; Rhabditida Infections; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael J Beach, Ph.D.

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Byron Arana, MD

  MERTU/CDC-Universite de Valle de Guatemala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2005
• Study Completion: March 1, 2005
• Last Updated: November 17, 2005

Record last verified: 2005-09

Locations

GU (1)