Soil-transmitted helminthiasis Infections and Infestations Other helminthiases
Conditions
Interventions
Four treatment groups as follows:
1. Single-dose albendazole
children will receive one tablet of albendazole (400 mg) and a placebo resembling ivermectin (number of tablets according to weight)
2. Mebendazole
children will receive a single dose of mebendazole (500 mg) and a placebo resembling ivermectin (number of tablets according to weight)
3. Albendazole plus ivermectin
children will receive one tablet of albendazole (400 mg) plus ivermectin tablets according to their weight (200 µg/kg)
4. Mebendazole plus ivermectin
children will receive one tablet of mebendazole (500 mg) plus ivermectin tablets according to their weight (200 µg/kg)
The treatment for the four arms will be administered on a single day
follow-up is 3 - 4 weeks post-treatment.
Sponsors
Swiss Tropical Institute (STI) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cure rate of Trichuris trichiura infection (percentage of children with egg counts greater than 0 before treatment who become negative after treatment) 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
| Measure | Time frame |
|---|---|
| Cure rate and egg reduction rate of Ascaris lumbricoides and hookworm | — |
Countries
Tanzania
Outcome results
None listed