Efficacy and safety of anti-worm drugs in schoolchildren in Zanzibar, Tanzania

Completed

Conditions: Soil-transmitted helminthiasis
Infections and Infestations
Other helminthiases

Registration Number: ISRCTN08336605

Lead Sponsor: Swiss Tropical Institute (STI) (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2000

Inclusion Criteria

1. Aged greater than or equal to 5 years, both sexes
2. Submission of one stool sample of sufficient size to perform a total of two thick Kato-Katz smears at the baseline parasitological survey
3. Submission of one stool sample of sufficient size to perform a total of two thick Kato-Katz smears at the day of treatment
4. Infection with Trichuris trichiura as determined with the Kato-Katz method at the baseline survey. Additionally, also children with A. lumbricoides and/or hookworm infections will be included in one of the four treatment arms.
5. For females, not pregnant, as verbally assessed by medical personnel on the day of treatment
6. Absence of major systemic illnesses, as assessed by female medical personnel on the day of treatment
7. No anthelminthic treatment in the past 4 weeks, as verbally confirmed by the participant at the baseline survey
8. Written informed consent by the parent/legal guardian

Exclusion Criteria

1. No stool sample given at baseline survey or day of treatment
2. No infection with T. trichiura, A. lumbricoides and/or hookworm at baseline
3. Subjects with fever or other signs of acute illness
4. Subjects with severe neurological disorder
5. Subjects with severe liver disorder
6. Pregnant schoolgirls
7. Recent history of anthelminthic treatment
8. Consent not given

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cure rate of Trichuris trichiura infection (percentage of children with egg counts greater than 0 before treatment who become negative after treatment)<br>2. Egg reduction rate of Trichuris trichiura infection (reduction in egg count in a measured quantity of faeces following treatment in those not cured)

Secondary Outcome Measures