Addition of low dose primaquine to artemether-lumefantrine for the treatment of uncomplicated malaria

Not Applicable

• Conditions: Malaria

• Registration Number: PACTR201611001859416
• Lead Sponsor: niversity of Cape Town

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

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