Status:
COMPLETED
Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Malaria Research and Training Center, Bamako, Mali
Radboud University Medical Center
Conditions:
Malaria,Falciparum
Eligibility:
All Genders
5-50 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Protocol will be shared on request
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04049916
Start Date
September 12 2019
End Date
January 7 2020
Last Update
January 30 2020
Active Locations (2)
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1
Malaria Research and Training Centre
Bamako, Mali
2
Radboud university medical center
Nijmegen, Netherlands