Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine
Status:
Completed
Trial end date:
2020-12-23
Target enrollment:
Participant gender:
Summary
In Nigeria, malaria is the commonest reason for outpatient clinic attendance in childhood and
is responsible for about 20% of childhood deaths. The emergence of strains of P. falciparum
resistant to chloroquine and sulfadoxine-pyrimethamine led to severe worsening of morbidity
and mortality from malaria. As a result of resistance to previously used monotherapy, the
World Health Organization (WHO) in 2001, recommended that malaria-endemic countries
experiencing drug-resistant malaria infection adopt combination therapy. Artemisinin-based
combination therapy (ACT) is preferred to the non-ACT combination. In this randomized
open-label clinical trial, the safety and efficacy of pyronaridine-artesunate and
artemether-lumefantrine in the treatment of malaria among children aged 3 to 120 months who
have microscopically confirmed symptomatic Plasmodium falciparum malaria were compared. The
study was carried out at the Oni Memorial Children's Hospital, Ring Road Ibadan. One hundred
and seventy-two children between 3 and 120 months who meet the inclusion criteria will be
enrolled after obtaining written or witnessed signed informed consent from the parents or
guardian. A detailed history and physical examination were carried out on each enrollee.
Finger prick blood samples were taken from each enrolee for thick blood smear for malaria
parasite, haematocrit, and blood spots on filter paper. Five millilitres of venous blood will
be taken from an arm vein for baseline liver function tests, creatinine, and random blood
glucose on days 0, 3, 7 and 28. Enrollees were randomized into one of two groups. Group one
received pyronaridine-artesunate while group two received artemether-lumefantrine at standard
doses. Enrollees were seen daily from days 0-3, and on days 7, 14, 21 and 28. Study drugs
were administered supervised at standard dosage on days 0, 1, and 2. History taking, physical
examination and blood smears were done at each contact time. Special attention will be paid
to adverse effects. Parasite clearance time, fever clearance time and cure rates were
compared between the two groups.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Ibadan
Collaborators:
Institute for Advanced Medical Research and Training, University of Ibadan, Ibadan Shin Poong Pharm Co Ltd 161 yoksam-ro, Gangnam-Gu Seoul 135-925, Korea
Treatments:
Antimalarials Artemether Artemether, Lumefantrine Drug Combination Artesunate Lumefantrine Pyronaridine