Sarr (started 2014)

Trial name or title	A trial of the safety of low dose primaquine in addition to ACTs commonly used in Senegal
Methods	Parallel, randomized
Participants	300 participants will be recruited in Senegal Inclusion criteria: 1. Age minimum: 20 years old, age maximum: 50 years old 2. Gender: Both 3. Adult patients with acute uncomplicated P. falciparum malaria 4. P. falciparum monospecific infection with parasite density ranged from 1000 to 100,000 trophozoite/µL 5. Willingness to participate in the planed study investigations and to remain in the study area for the duration of the study 6. Participants informed consent 7. Absence of known chronic illness such as hypertension, diabetes, renal and liver disease
	Exclusion criteria: 1. Known allergy to the study medications 2. Presence of severe anaemia (haemoglobin 8 g/dL) at enrolment 3. Pregnancy, or breastfeeding
Interventions	Control: ACT treatment, standard malaria treatment, 1 daily dose, 3 days duration (N = 150) Experimental: ACT plus PQ treatment; ACT treatment 1 daily dose for 3 days, PQ single low dose 0.25 mg/kg at day 1 (N = 150)
Outcomes	Primary outcome 1. Mean haemoglobin difference from day 0 to day 7 after treatment with ACT and PQ
	Secondary outcomes 1. Mean haemoglobin level at day 14 of follow-up in each treatment arm 2. Mean haemoglobin level at day 28 of follow-up in each treatment arm
Starting date	Registered 10/11/2014; Date of first enrolment 15 November 2014
Contact information	roger.tine@ucad.edu.sn +00 221 77 637 05 31 (Prof Roger Tine) bathie65@yahoo.fr +00 221 77 647 09 99 (Dr Samba Cor Sarr) khadimesylla@yahoo.fr +00 221 77 521 76 44 (Dr Khadime Sylla)
Notes	Pan African Clinical Trials identifier: PACTR201411000937373 Primary sponsor: University Cheikh Anta DIOP of Dakar