Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission

• Status: Completed
• Trial end date: 2020-01-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the gametocytocidal and transmission reducing activity of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP) with and without a single low dose of primaquine (PQ; 0.25mg/kg). Outcome measures will include infectivity at 2 and 7 days after treatment, the duration of infectivity in the artemisinin combination therapy (ACT) only arms, and the production and detectability of histidine rich protein II.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Malaria Research and Training Center, Bamako, Mali; Radboud University
• Treatments: Artemisinins; Artenimol; Artesunate; Dihydroartemisinin; Piperaquine; Primaquine; Pyronaridine

Criteria

Inclusion Criteria:

• Age ≥ 5 years and ≤ 50 years

• Absence of symptomatic falciparum malaria, defined by fever on enrolment

• Presence of ≥16 gametocytes/µL (i.e. ≥1 gametocytes recorded in the thick film against 500 white blood cells)

• No allergies to study drugs

• Use of antimalarial drugs over the past 7 days (as reported by the participant)

• Hemoglobin ≥ 9.5 g/dL

• Individuals weighing >< 80 kg

• No evidence of severe or chronic disease

• Written, informed consent

Exclusion Criteria:

• Age < 5 years or > 50 years

• Pregnancy

• Previous reaction to study drugs/known allergy to study drugs

• Signs of severe malaria

• Taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine)

• Blood transfusion within the last 90 days

• Patients with clinical signs or symptoms of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage B or C).

• Patients with clinical signs or symptoms of renal impairment or known renal impairment

• 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.

• 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.

• Consent not given