Tiono (started 2013)

Trial name or title	Low Dose Primaquine for Clearance of Gametocytes: LOPRIM-1
Methods	Randomized, parallel assignment, double blind (subject, caregiver, investigator, outcomes assessor); safety/efficacy study
Participants	Target sample size 360 participants Inclusion criteria • Age = 2 and < 15 years • P. falciparum parasitaemia = 1000 and < 200,000 parasites/µL • P. falciparum gametocytes • Normal G6PD • Informed consent by legally acceptable representative
	Exclusion criteria • Enrolled in another study • Fever or history of fever in last 24 hours • Evidence of severe illness/danger signs • Known allergy to study medications • Hb < 8 g/dL • Started menstruation • Pregnancy or breastfeeding • Antimalarials taken within last 2 days • PQ taken within last 4 weeks • Blood transfusion within the last 90 days • Non-falciparum malaria co-infection
Interventions	Group 1: AL Group 2: AL with a single dose of 0.25 mg/kg PQ Group 3: AL with a single dose of 0.4 mg/kg PQ
Outcomes	Primary: Gametocyte carriage (time frame: 14 days during follow-up) Secondary: • Haematological recovery (time frame: 14 days during follow-up) • Transmission to An. gambiae mosquitoes (time frame: day 1, 3, and 7
Starting date	September 2013
Contact information	t.alfred@fasonet.bf; teun.bousema@lshtm.ac.uk
Notes	ClinicalTrials.gov identifier: NCT01935882 Burkina Faso, Centre National de Recherche et de Formation sur le Paludisme, Ougadougou, Burkina Faso.