Soil-transmitted helminths Paediatrics
Conditions
Interventions
Albendazole
FDCx1. Albendazole and Ivermectin Fixed Dose Coformulation
FDCx3. Albendazole and Ivermectin Fixed Dose Coformulation 3 days
Sponsors
Barcelona Institute for Global Health ISGlobal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Positive infection test by microscopy for at least one of the following STH: T. trichiura, hookworms and/or larvae of S. stercoralis. Weight =15 Kg. Male or female, aged 5 to 18 years. Female participants who are =12 years old (or female post-menarche) must have a negative urine pregnancy test at screening or at the time of randomization. Ability to take oral medication and willingness to comply with all study procedures. Parental acceptance to participate in the study by obtaining a signed and dated informed consent form approved by the Regulatory authorities. In addition, verbal assent will be obtained from children aged 12–18 years.
Exclusion criteria
Exclusion criteria: Intake of ALB, mebendazole and/or IVM, or any potentially interacting drug three months before screening. Residence outside the study area or planning to move away in the four weeks following recruitment. Epidemiological risk of infection by Loa loa. Serious medical illness, per investigator’s criteria. Any participant’s condition that would prevent the appropriate evaluation and follow-up, as per investigator’s criteria. Known hypersensitivity to any components of either of the study treatment. Positive pregnancy urine test, pregnant or first week post-partum.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate (CR) for T. trichiura 21 days after treatment, as determined by microscopy (efficacy T. trichiura). | — |
Secondary
| Measure | Time frame |
|---|---|
| CR for hookworm and S. stercoralis 21 days after treatment, as determined by microscopy (efficacy hookworm and S. stercoralis).;Egg reduction rate (ERR) for T. trichiura 21 days after treatment, by microscopy.;Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for ALB, FDC and FDCx3 (safety).;CR for T. trichiura, hookworm and S. stercoralis, by PCR.;Parasite burden decrease after 21 days for hookworm, T. trichiura and S. stercoralis, by PCR.;Evaluation of genotypic albendazole resistance in the three arms. | — |
Countries
Ethiopia, Kenya, Mozambique
Contacts
Public ContactMarc Fernandez Pardos
Project Manager
Outcome results
None listed