Malaria
Conditions
Interventions
Albendazole
Ivermectin
Sponsors
Barcelona Institute for GlobalHealth
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For human treatment/safety cohort: • Residents of the study area • Male or female weighing more than 15kg • Adult able to provide written consent • Minors aged 12 to 17 able to provide assent • Parent/guardian’s able to provide consent for minors • Negative pregnancy test for women aged between 13 and 49 • Agreement to adhere to study visits and procedures For pediatric active cohort: • Children in the age of highest burden at the time of enrollment (under 5 years of age in Mozambique or 5-15 in Kenya) • Residents of the study area • Parent/guardian’s able to provide consent for minors • Minors aged 12 to 15 in Kenya able to provide assent For cross sectionals: • Residents of the area for at least 3 months prior to enrolment • Parent/guardian’s consent for minors • Ability to provide assent for minors aged 12 to 17 years • Written consent from adults For livestock treatment: • Owner/guardian able to provide consent • Animal expected to spend at least one week every study month inside the cluster border
Exclusion criteria
Exclusion criteria: For human treatment/safety cohort: • Known hypersensitivity to ivermectin or albendazole • Risk of Loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria or Sudan • Pregnant women • Lactating women in the first week postpartum • Children <15 kg • Currently participating in another clinical trial • Unwilling to provide informed consent or assent • Unwilling to adhere to study visits and/or procedures • Severely ill either self-reported or in the eyes of the investigator, e.g. defined as need for clinical care, or active or progressive disease interfering with activities of daily living. If in doubt, these criteria can be confirmed after a call with either the site PI/MD/safety officer against a pre-defined list. • Currently under treatment with inhibitors of CYP3A or P-gp or other drugs that can interfere with the study For incidence cohort: • Non-residents • Currently enrolled in other clinical trial For cross sectionals: • Non-residents For livestock treatment (Mozambique): • Received ivermectin three weeks than four weeks ago • Intention to milk or slaughter the animal for human consumption during the withdrawal period (28 days after dosing) • Calves under 8 weeks and piglets under 6 weeks of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To determine the safety (in humans) and efficacy of ivermectin MDA, administered to humans or humans and livestock simultaneously (only in Mozambique), for the prevention of malaria. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess the efficacy of the intervention using complementary methods (efficacy) • To assess the safety of the intervention with complementary methods (safety) • To assess the pharmacokinetics (PK) of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety) • To assess the impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic neglected tropical diseases (NTDs). • To assess the relationship between malaria incidence in children under 5 years old in Mozambique and 5-15 years old in Kenya and community prevalence one month post last dose (Mozambique) • To assess the relationship between active and passive surveillance for malaria at health facility (Mozambique) • To assess the accuracy for malaria diagnosis of two different malaria rapid diagnostic tests (RDTs) used in comparison to polymerase chain reaction (PCR) (this is directly linked to efficacy as determined by RDTs) | — |
Countries
Kenya, Mozambique
Contacts
Public ContactMary Mael
Administrator
Outcome results
None listed