Soil-transmitted helminths Paediatrics
Conditions
Interventions
Albendazole
FDC Albendazole and Ivermectin
Sponsors
Laboratorios Liconsa SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age: 5 to 17 years old (included). - Height: over 90cm. - Parental acceptance to participate in the study by obtaining written informed consent approved by the Ethics Committee. Written assent will also be obtained from children according to the local national legislation. (In Kenya written assent will be obtained from children 12-17 years old and in Ghana for children 15-17 years old.)
Exclusion criteria
Exclusion criteria: - Epidemiological risk of being infected by Loa loa. - Serious medical illness, per investigator’s criteria. - Any condition prevents the appropriate evaluation and follow-up of the participant, per the investigator’s criteria. - Known hypersensitivity to any component of either study treatment. - Pregnant or first week post-partum, reported by the participant during interview.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, type and severity of related AEs and SAEs for FDC and ALB | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in T. trichiura prevalence determined by microscopy for FDC and ALB. | — |
Countries
Ghana, Kenya
Contacts
Public ContactCelia Olmos
Project Manager Laboratorios Liconsa
Outcome results
None listed