Efficacy Albendazole and Levamisole Against STH on Unguja

NCT00659997 | Completed Phase 4

• 1 other identifier: NHMDEWORMING
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Field epidemiological studies undertaken during 2005 in four village locations in Northern Unguja, Zanzibar examined mothers and their pre-school aged children for helminth infections. The prevalence of Ascaris lumbricoides was found to have remained relatively high despite community-wide treatment with the mass administration of Albendazole (a WHO recommended de-wormer) in coordination with community vitamin A supplementation. One hypothesis for this is that the children and mothers had Ascaris infections more tolerant to Albendazole that subsequently failed to clear. It is necessary to compare the present drug efficiency of Albendazole (first-line de-wormer) with Levamisole (second-line de-wormer) on STH infections such patients a case-control setting to shed light on the putative resistance of local Ascaris/Trichuris to albendazole. In so doing, this should clarify whether there is resistance developing towards Albendazole and have possible implications for introducing combination therapies of Levamisole and Albendazole for first line de-worming mothers and their children in the future.

Conditions

Ascariasis; Trichuriasis

Keywords

Ascariasis; Trichuriasis; Drug resistance

Outcome Measures

Primary Outcomes (1)

• Clearance of STH faecal eggs in patient stool

  18 days

Study Arms (2)

1

ACTIVE COMPARATOR

1 Individuals treated with Albendazole

Drug: Albendazole

2

ACTIVE COMPARATOR

Individuals treated with Levamisole

Drug: Levamisole

Interventions

Albendazole DRUG

Single oral dose of 400mg

1

Levamisole DRUG

Single oral dose of 2.5mg/kg

2

Eligibility Criteria

• Age: 1 Year - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Presently with soil-transmitted helminthiasis

You may not qualify if:

• absence of soil-transmitted helminthiasis

Sponsors & Collaborators

• Natural History Museum, United Kingdom: lead
• Ministry of Health, Tanzania: collaborator
• University of London: collaborator

Study Sites (1)

Helminth Control Laboratory Unguja

Stone Town, Tanzania

Location

Related Publications (1)

• Stothard JR, Imison E, French MD, Sousa-Figueiredo JC, Khamis IS, Rollinson D. Soil-transmitted helminthiasis among mothers and their pre-school children on Unguja Island, Zanzibar with emphasis upon ascariasis. Parasitology. 2008 Oct;135(12):1447-55. doi: 10.1017/S0031182008004836. Epub 2008 Sep 8.

  PMID: 18775092 RESULT

MeSH Terms

Conditions

Ascariasis; Trichuriasis

Interventions

Albendazole; Levamisole

Condition Hierarchy (Ancestors)

Ascaridida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Enoplida Infections; Adenophorea Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 17, 2008
• Study Start: June 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2007
• Last Updated: April 17, 2008

Record last verified: 2008-04

Locations

TA (1)