Mwaiswelo (started 2014)

Trial name or title	Efficacy and Safety of a Single Low-dose Primaquine Added to Standard Artemether-lumefantrine Treatment for the Clearance of Plasmodium Falciparum Gametocytes
Methods	Phase 4, randomized, safety/efficacy study, parallel assignment, single blind (subject). Primary purpose: Prevention
Participants	Target sample size (N = 220) in Tanzania Inclusion criteria: 1. Gender: Both 2. Age of 1 year and above and neither pregnant nor breast feeding 3. Weight over 10 kg 4. Body temperature = 37.5°C or history of fever in the last 24 hours 5. P. falciparum mono-infection
	Exclusion criteria: 1. Evidence of severe illness malaria or danger signs 2. Known allergy to study medications 3. Hemoglobin < 8 g/dL 4. Antimalarials taken within last 2 weeks 5. Blood transfusion within last 90 days and evidence of recent use (within 14 days) of or will be taking other drugs known to cause hemolysis in G6PD-deficient subjects
Interventions	Control: AL + placebo. The first dose of AL will be administered concomitantly with a single-dose placebo. A volume of normal saline will be measured based on weight bands and then will be given to patients. Intervention: AL+PQ. All the recruited patients will be treated with a six doses, 3 days AL treatment regimen. However, patients randomized to the AL+PQ arm will be given 0.25 mg/kg single-dose PQ concomitantly with AL first dose.
Outcomes	Primary outcome: Number of days per treatment arm for gametocytes to become undetectable using Quantitative nucleic acid sequence based assay (QT-NASBA) (time frame: 14 days) Secondary outcome: Mean maximal fall in haemoglobin (g/dL) from enrolment to day 28 of follow-up defined as mean greatest negative difference in haemoglobin per treatment arm (time frame: 28 days)
Starting date	Date of registration 16 March 2014 Date of first enrolment July 2014
Contact information	richiemwai@yahoo.com +255 717 043 970 (Richard O Mwaiswelo, MSc. PE) Andreas Martensson, PhD, Karolinska Institutet
Notes	ClinicalTrials.gov identifier: NCT02090036 Primary sponsor: Muhimbili University of Health and Allied Sciences Secondary sponsor: Karolinska Institutet