Malaria
Conditions
Interventions
Artemether lumefantrine or Chloroquine and Primaquine ABC in patient with normal G6PD
Artemether lumefantrine or Chloroquine and Primaquine BAC in patient with normal G6PD
Artemether lumefantrine or Chloroquine and Primaquine CAB in patient with normal G6PD
Artemether lumefantrine or Chloroquine and Primaquine for G6PD deficiency group
Sponsors
The Masters and Scholars of the University of Oxford University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those living within 20 km of the catchment of the health facility with a traceable address or phone contact number 2. Parent/legal guardian is willing to comply with the study protocol and visit schedule, including attendance in person for all necessary visits at study site 3. Able to give assent for patients aged 12 – 16 years and Parental/legal guardian informed written consent 4. Age = 6 months and < 16 years at the time of consent 5. Weight = 5.0 kg 6. Slide-confirmed P. vivax mono- or mixed infections 7. Axillary temperature = 37.5º C or history of fever during the previous 10 days 8 Ability to swallow oral medication
Exclusion criteria
Exclusion criteria: 1. General danger signs or symptoms of severe malaria 2.Haemoglobin (Hb) <5 g/dL 3. Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, COVID-19, severe diarrhoea with dehydration) 4. COVID-19 positive by a lateral flow antigen test (Follow the Ethiopian Public Health Institute's guidelines and recommendations for testing. 5. Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease) 6. History of hypersensitivity to study or rescue medication in this study 7. Taking regular medication which may interfere with antimalarial PK or efficacy 8. Severe malnutrition in a child aged between 6-59 months as defined by the presence of symmetrical oedema involving at least the feet or a mid-upper arm circumference < 115 mm 9. Known pregnancy or UPT positive at the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the antirelapse efficacy and safety of daily or weekly primaquine using new generic formulations in children aged 6m to < 16 years in Ethiopia | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determine the haematological response of daily or weekly primaquine using new generic formulations in children aged 6m to < 16 years 2. Evaluate the acceptability of new generic PQ regimes in vivax malaria patients 6m to < 16 years 3. Characterise PQ and carboxyPQ disposition 4. Assess CQ exposure 5. Characterise cytochrome P450 2D6 activity 6. Characterise host genetics for inherited blood disorders 7. Determine Day 28 parasitological and clinical efficacy 8. Determine asexual parasite and gametocyte dynamics 9. Determine parasite genetics 10 .Assess socioeconomic factors related to malaria | — |
Countries
Ethiopia
Contacts
Public ContactDemekech Damtie
Secretariat of the Ethics Review Committee
Outcome results
None listed