Addition of low dose primaquine to artemether-lumefantrine for the treatment of uncomplicated malaria
- Conditions
- Malaria
- Registration Number
- PACTR201611001859416
- Lead Sponsor
- niversity of Cape Town
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 140
Plasmodium falciparum positive by RDT
Age > 2 years
Weight over 10 kg
Prescribed artemether-lumefantrine according to standard practice
Informed consent (by legally acceptable representative if under 18 years of age)
Assent in children aged 7 and above
Intention to remain in the study area for the duration of the follow-up period
Evidence of severe illness/ danger signs
Known allergy to study medications
Medical history of haemolysis, rheumatoid arthritis, lupus erythematosus or cardiac disease
In patients receiving concurrently other drugs that are cause hemolysis, bone marrow suppression or QTc interval prolongation
Hb < 7 g/dL
A decrease in Hb of > 2 g/dL between day 0 and day 3 prior to primaquine dose
Currently menstruating
Pregnant or breastfeeding
History of any antimalarials (including primaquine) taken within the last 4 weeks
Blood transfusion within the last 90 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in gametocyte prevalence on days 7 and 14 using RT-PCR;Change in mean haemoglobin (Hb) as measured by HemoCue on day 3
- Secondary Outcome Measures
Name Time Method Prevalence of severe anaemia, haemoglobinuria and adverse events;Efficacy of artemether-lumefantrine by asexual parasite recrudescence and reinfection rates over 42 days;Prevalence of molecular markers associated with artemesinin and lumefantrine resistance;Prevalence of G6PD deficiency using CareStart G6PD RDT;Sensitivity and specificity of CareStart G6PD RDT;Day 7 blood concentration of lumefantrine;Prevalence of G6PD mutant variants;Prevalence of CYP2D6 mutant alleles;Sensitivity and specificity of LAMP compared to PCR for detecting falciparum malaria