Parasitic Diseases
Conditions
Brief summary
This randomised, controlled, double blinded clinical study investigates the safety and efficacy of the combination of albendazole, ivermectin and praziquantel in the treatment of children aged 5-18 years co-infected with lymphatic filariasis, schistosomiasis and soil-transmitted helminthiasis.
Interventions
DRUGalbendazole + ivermectin + praziquantel
albendazole (400 mg one dose) + ivermectin 200 microgram/kg body weight) + praziquantel (40 mg/kg)
DRUGalbendazole + ivermectin + (1 week later) praziquantel
albendazole (400 mg one dose) + ivermectin (200 microgram/kg body weight) + (1 week later) praziquantel (40 mg/kg)
Sponsors
DBL -Institute for Health Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Those who will be in class one to six by the time of study * Aged 5-18 years and found infected with either SCH, any STH or LF for treatment groups 1,2 or 3 or infected with both SCH and LF for treatment group 4 and infected with all the three for treatment group 5 * Who are willing and consent and whose parents will consent, will be included in the study.
Exclusion criteria
* Those with acute and chronic diseases other than the targeted infections and those with a history of any serious adverse drug reactions will not be included in the study. * Children with total bilirubin \> 50µmol/L and ALAT (Alanine transferase) \> 70IU/L will not qualify for recruitment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse reactions | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of treatment | 6 weeks |
Countries
Uganda
Outcome results
None listed