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

A randomised controlled trial to investigate the efficacy, safety and tolerability of adding a single low primaquine dose to artemether-lumefantrine for the treatment of symptomatic uncomplicated Plasmodium falciparum malaria

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201611001859416

Enrollment

140

Registered

2016-11-11

Start date

2016-11-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Standard of care (artemether-lumefantrine)

Primaquine plus standard of care (artemether-lumefantrine)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

South Africa

Contacts

Public ContactKaren Barnes

Acting Head of Division of Clinical Pharmacology

karen.barnes@uct.ac.za+27214066008

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026