D'Alessandro (started 2013)

Trial name or title	Primaquine's Gametocytocidal Efficacy in Malaria Asymptomatic Carriers Treated With Dihydroartemisinin-Piperaquine in The Gambia
Methods	Randomized, open label
Participants	1200 participants will be recruited Inclusion criteria: • Age ≥ 1 year • Weight = 10 kg • P. falciparum mono-infection, density of at least 20 parasites/μL • Axillary temperature < 37.5°C • Resident in the trial area and willingness to reside for the duration of the trial • Written informed consent (plus an assent in children = 12 years of age)
	Exclusion criteria: • G6PD deficiency haemoglobin < 8 g/dL • Known allergy to any of the trial medications • Known pregnancy or breastfeeding • Clear/documented history of anti-malarial treatment two weeks before contact with trial team • History of blood transfusion in the previous three months • Any chronic or acute conditions that might interfere with the trial as judged by the research clinician • History of sickle cell anaemia
Interventions	1. Control: complete course of DHA-PPQ (Eurartesim) 2. Experimental: DHA-PPQ plus single dose PQ at 0.75 mg/kg body weight 3. Experimental: DHA-PPQ plus single dose PQ at 0.4 mg base/kg body weight 4. Experimental: DHA-PPQ plus single dose PQ at 0.2 mg base/kg body weight
Outcomes	Primary: Prevalence of P. falciparum gametocyte carriers (QT-NASBA) (time frame: Day 7) Secondary: 1. Prevalence of P. falciparum gametocytes carriers on days 3, 10, 14, 28 and 42 as determined by QT-NASBA 2. Proportion of individuals infectious to mosquitoes (DMFA) on day 7, with direct membrane feeding assay 3. Haemoglobin change from day 0 on days 3, 7, 10, 14, 21, 28, 35 and 42, as mean (±SD) difference in haemoglobin measured between baseline (day 0) and each follow-up visit day by trial arm 4. Prevalence of infection (asexual stages) on day 3 5. Proportion of participants with recurrent infection (PCR adjusted and unadjusted) from day 7 to day 42 6. Occurrence of adverse events and serious adverse events
Starting date	August 2013; December 2014 (final data collection date for primary outcome measure)
Contact information	udalessandro@mrc.gm +220-4495442-6 ext 4001 (Umberto D'Alessandro) jokebe@mrc.gm +220-4495442-6 ext 4009 (Joseph Okebe)
Notes	ClinicalTrials.gov identifier: NCT01838902