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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00659997
Other study ID # NHMDEWORMING
Secondary ID
Status Completed
Phase Phase 4
First received April 10, 2008
Last updated April 15, 2008
Start date June 2006
Est. completion date September 2007

Study information

Verified date April 2008
Source Natural History Museum, United Kingdom
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Albendazole
Single oral dose of 400mg
Levamisole
Single oral dose of 2.5mg/kg

Locations

Country Name City State
Tanzania Helminth Control Laboratory Unguja Stone Town

Sponsors (3)

Lead Sponsor Collaborator
Natural History Museum, United Kingdom Ministry of Health, Tanzania, University of London

Country where clinical trial is conducted

Tanzania, 

References & 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clearance of STH faecal eggs in patient stool 18 days No
See also
  Status Clinical Trial Phase
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Completed NCT06037876 - Efficacy of Ivermectin-albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura Phase 3
Completed NCT03527745 - Albendazole Dose Finding and Pharmacokinetics in Children and Adults Phase 2
Not yet recruiting NCT04713787 - A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults Phase 2
Active, not recruiting NCT06188715 - Efficacy and Safety of MOX/ALB Co-administration in SAC Phase 3
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Recruiting NCT06184399 - Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC Phase 2
Completed NCT04726969 - Efficacy and Safety of MOX/ALB Co-administration Phase 3
Not yet recruiting NCT05706116 - Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults Phase 1
Completed NCT00207753 - Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections N/A