Malaria Infections and Infestations Malaria
Conditions
Interventions
1. AS+PQ= One tablet of artesunate contains 50 mg base. Artesunate alone will use the same artesunate tablet from co-blister of Arsuamoon™ used by Ind MoH for malaria therapy. Arsuamoon™ manufactured
100 mg days 1-6). After a 48hr pause, 0.5 mg/kg primaquine in tablets containing 26.3 mg of primaquine phosphate (15 mg base) daily for days 8 to 21. Primaquine manufactured by Sanofi, France.
2. PY
Sponsors
ALERTAsia Foundation (Indonesia)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older, but younger than 65 years 2. Travelled for >1 month to northeastern Papua within the past 12 months 3. Body weight >40 kg and = 90 kg 4. A diagnosis of P. vivax parasitemia, mono- or mixed-species infection of any density and confirmed by a second microscopist 5. Written informed consent provided by participants 6. Glucose-6-phosphate dehydrogenase (G6PD) normal using the NADPH qualitative fluorescent spot test (Trinity Biologicals, USA) 7. Able to swallow oral medication
Exclusion criteria
Exclusion criteria: 1. Patient confirmed as having Plasmodium falciparum mono infection 2. Patient requires hospitalization for any reasons 3. Haemoglobin 450 ms*. 7.2. Active Hepatitis A, e.g. by detection of anti HAV-IgM. 7.3. Hepatitis B surface antigen (HBsAg) carrier. 7.4. Hepatitis C antibody (HCV Ab). 7.5. Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range. 7.6. Renal impairment as indicated by abnormal creatinine clearance of <60 ml/min, measured using Cockcroft-Gault formula. 8. Known history of hypersensitivity, allergy or adverse reactions to primaquine, artesunate, dihydroartemisinin (DHA), pyronaridine or other artemisinins. 9. Previous participation in the present clinical trial, i.e., subjects experiencing relapse may not be enrolled and randomized as a new subject. 10. Have received any investigational drug within the past 4 weeks. 11. Anyone of the following contra indications of DHA-PQP, such as: 11.1. Family history of sudden unexplained death. 11.2. Known congenital QTc prolongation. 11.3. Known presence of a medical condition known to prolong the QT interval: myxoedema, cardiomyopathies, recent myocardial infarction. 11.4. History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia. 11.5. Cardiac illnesses predisposing to arrythmias e.g. hypertension, left ventricular hypertrophy, cardiomyopathies, cardiac failure with reduced ejection fraction. 11.6. Presence of an electrolyte disturbance particularly hypokalaemia, hypocalcaemia, hypomagnesaemia. 11.7. On any drug known to prolong the QTc interval, including: 11.7.1. Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol). 11.7.2. Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) and antidepressive agents. 11.7.3. Certain antimicrobial agents, including agents of the following classes: macrolides (e.g. erythromycin, clarithromycin), fluoroquinolones (e.g. moxifloxacin, sparfloxacin), imidazole and triazole antifungal agents and also pentamidine and saquinavir. 12. Recent treatment with medicinal products known to prolong the QTc interval that may still be circulating at the time that Eurartesim is commenced (e.g. mefloquine, halofantrine, lumefantrine, chloroquine, quinine and other antimalarial agents) taking into account their elimination half-life. * We will use the Fridericia formula (QTcF=QR/(RR)0.3 or Bazett?s formula (QTcF=QR/(RR)0.5 whichever is lower.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To obtain independent, high precision estimates of the efficacy of standard primaquine therapy when combined with PYR-AS or DHA-PQP for radical cure of acute malaria caused by P. vivax. Efficacy of relapse is calculated as: (natural relapse rate - relapse rate post-PQ) / natural relapse rate x 100% Measured by following up for 365 days, counting the first day of study drug administration as Day 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Measure the efficacy of the blood schizontocides against acute vivax malaria, documenting safety and pharmacokinetic characteristics of the drug regimens, and their tolerability through monitoring adverse events. Measured by following up for 365 days, counting the first day of study drug administration as Day 0 | — |
Countries
Indonesia
Outcome results
None listed