Tekete 2012 AF.

Trial name or title	EDCTP Longitudinal study
Methods	Trial design: An open‐label RCT Follow‐up: Patients will receive same study drug for subsequent episodes of uncomplicated malaria for up to 2 years after first randomization. Haematology, biochemistry and clinical safety will be assessed over this two year period.
Participants	Number of participants: 4032 Inclusion criteria: Acute uncomplicated malaria, age > 6 months, weight ≥ 5 kg with no clinical sign of severe malnutrition, axillary temp > 37.5 °C, oral/rectal/tympanic temperature > 38 °C or history of fever in the last 24 hrs, microscopically confirmed P. falciparum with parasite density less than 200,000/µL, ability to swallow oral medication, no documented malaria treatment in preceding 2 weeks or 4 weeks for re‐inclusion, the ability to participate in the scheduled follow‐up visits, written informed consent Exclusion criteria: Signs and symptoms of severe/complicated malaria, severe vomiting (more than 3 times in preceding 24hrs) or inability to tolerate oral medication, severe diarrhoea (3 or more watery stools per day), known history of clinically significant disorders such as cardiovascular (QTc interval > 450 ms), respiratory (including active tuberculosis), history of jaundice, renal, hepatic, gastrointestinal, immunological (including active HIV), neurological, endocrine, or other major psychiatric disorders, history of convulsions or other abnormality (including recent head trauma), Hb < 7 g/dL, concomitant febrile illness, hypersensitivity to study drugs, use of any other antimalarial in preceding 2 weeks before enrolment, pregnant or lactating women, known or suspected chronic alcohol abuse, active Hepatitis A, B or C, liver function tests > 2 times upper limit of normal, known significant renal impairment indicated by serum creatinine more than 1.5 x ULN
Interventions	1. DHA‐P, fixed dose combination, adult tablets 40 mg/320 mg, child tablets 20 mg/160 mg (Eurartesim®: Sigma Tau) One dose daily for 3 days 2. Artemether‐lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) Dose based on body weight between 2 to 4 tablets/day Children given dispersible tablets Once daily for 3 days 3. Artesunate‐Amodiaquine, fixed dose combination, 3 strengths: 25 mg/67.5 mg, 50 mg/135 mg, 100 mg/270 mg (Winthrop: Sanofi‐aventis) Once daily for 3 days 4, Artesunate‐Amodiaquine, fixed dose combination (Pyramax: Shin Poong) Dose based on body weight between 1 to 4 tablets/sachets per day Once daily for 3 days
Outcomes	Incidence rate of malaria Repeated treatment safety over 2 years Efficacy of study drugs according to WHO guidelines
Starting date	01 June 2011
Contact information	Principal investigator ‐ Dr Abdoulaye Djimde ‐ adjimde@mrtcbko.org
Notes	Country: Burkino Faso (2 centres), Mali (1 centre), Guinea (1 centre) Dates: 01 June 2011 to 29 June 2014 Funding: Medicines for Malaria Venture and European & Developing Countries Clinical Trials Partnership (EDCTP)