Sawa DAPPI-1 (started 2014)

Trial name or title	A Double Blind Randomized Controlled Trial of Dihydroartemisinin-Piperaquine Alone and in Combination With Single Dose Primaquine to Reduce Post-treatment Malaria Transmission
Methods	Phase 3 randomized, safety/efficacy study, parallel assignment, double blind (subject, caregiver, investigator, outcomes assessor)
Participants	120 participants will be recruited in Kenya Inclusion criteria: 1. Microscopically detectableP. falciparum gametocyte carriage 2. Age 5 years to 15 years 3. Gender: both
	Exclusion criteria: 1. Age < 5 years or = 15 years 2. Non-falciparum malaria co-infection 3. Malaria parasite density = 200,000 parasites/µL 4. Clinical symptoms indicating severe malaria 5. Axillary temperature = 39°C 6. Body Mass Index (BMI) below 16 or above 32 kg/m2 7. Haemoglobin concentration below 9.5 g/dL 8. Antimalarials taken in last 2 days 9. For women: Pregnancy (assessed by clinical examination and urine pregnancy test) or lactation 10. Known hypersensitivity to DP or PQ 11. History or symptoms, or both indicating chronic illness 12. Current use of tuberculosis or anti-retroviral medication 13. Unable to give written informed consent 14. Unwillingness to participate in two membrane feeding assays 15. Travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan 16. Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease 17. Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride 18. Known disturbances of electrolyte balance, eg hypokalaemia or hypomagnesaemia 19. Taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (for example, flecainide, metoprolol, imipramine, amitriptyline, clomipramine) 20. Blood transfusion within last 90 days
Interventions	Control: DHAP (Artekin) combination alone Experimental: DHAP (Artekin) combination alone plus single-dose 0.25 mg/kg PQ
Outcomes	Primary outcome 1. Gametocyte prevalence on day 7 after initiation of treatment (time frame: day 7 of follow-up)
	Secondary outcomes 1. Gametocyte carriage during follow-up (time frame: 14 days during follow-up) 2. Gametocyte sex-ratio (time frame: 14 days of follow-up) 3. Haematological recovery (time frame: 14 days during follow-up) 4. Transmission to An. gambiae mosquitoes (time frame: day 3 and 7 during follow-up)
Starting date	Registration date 29 September 2014; first enrolment October 2014
Contact information	psawa@icipe.org +254 59 22620 (Patrick Sawa MD, ICIPE) teun.bousema@lshtm.ac.uk +31243617574 (Teun J Bousema, PhD)
Notes	ClinicalTrials.gov identifier: NCT02259426 Primary sponsor: London School of Hygiene and Tropical Medicine