Arterolane-PQP Versus DHA-PQP in Uncomplicated Falciparum Malaria in Eastern Myanmar

This is an interventional treatment trial for Uncomplicated Falciparum Malaria focused on measuring Arterolane-piperaquine, Dehydroartemisinin-piperaquine, therapeutic efficacy, Uncomplicated falciparum malaria, Artemisinin-resistant Read More

Inclusion Criteria:

• Male or female aged ≥ 18 year old
• Symptomatic malaria infection, i.e. history of fever or presence of fever >37.5°c (tympanic) within the last 24 hours.
• Microscopic confirmation of asexual stages of P.falciparum (may be mixed with non-falciparum species) with a parasitaemia >10,000 parasites/µL
• Able to take oral medication
• Willingness and ability of patients to comply with the study protocol for the duration of the study
• Written informed consent given to participate in the trial

Exclusion Criteria:

• Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age 18 to 45 year old)
• P.falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175,000/µL).

• Signs or symptoms indicative of severe malaria:

  • Impaired consciousness
  • Severe anaemia (Hct<15%)
  • Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venipuncture sites
  • Respiratory distress
  • Severe jaundice
• Have taken a full course DHA-piperaquine, artemether-lumefantrin or other antimalarial treatment in the previous 42 days
• Known hypersensitivity to artemisinins or to piperaquine - defined as history of erythroderma/other severe cutaneous reaction or angioedema
• History of splenectomy

• History of taking medicinal products that are known to prolong the QTc interval, including:

  • Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
  • Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.

  • Certain antimicrobial agents, including agents of the following classes:

    • macrolides (e.g. erythromycin, clarithromycin),
    • fluoroquinolones (e.g. moxifloxacin, sparfloxacin),
    • imidazole and triazole antifungal agent,
    • pentamidine and saquinavir.
  • The non-sedating antihistamines terfenadine, astemizole, mizolastine.
  • Other drugs: cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
• History of taking any drug which is known to be metabolised by the cytochrome enzyme CYP2D6 including flecainide, metoprol, imipramine, amitriptyline, clomipramine.
• Family history of sudden unexplained death, or personal or family history of predisposing cardiac conditions for arrhythmia/QT prolongation (including congenital long QT syndrome, arrhythmia, QTc interval greater than 450 milliseconds with either Bazett or Fridericia correction).