A Phase 2/3 interventional study of Antimalarials, pyronaridine-artesunate and Antimalarials, Artemether + Lumefantrine in Malaria Fever, Plasmodium Falciparum Malaria and Uncomplicated Malaria, sponsored by University of Ibadan. Completed at 1 site in Nigeria. Open to participants aged 3 Months to 144 Months. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by University of Ibadan · Phase 2/3, Interventional, and Treatment
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 144 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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 172 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
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Exclusion Criteria:
Artesunate-pyronaridine is indicated for the blood-stage treatment of the two dominant strains of malaria: P. falciparum and P. vivax. The medicine is also available in a child-friendly granule formulation to enhance palatability in this vulnerable population. Dosing was administered according to body weight: 5 - \<8kg - one sachet daily for 3 days; 8 - \<15Kg - two sachets daily for 3 days; 15 - \<20 Kg - three sachets daily for 3 days; 20 - \<24 Kg - one tablet daily for 3 days; and 24 - \<45 Kg - two tablets daily for 3 days.
Drug: Antimalarials, pyronaridine-artesunate
We used the standard six-dose regimen of artemether-lumefantrine dispersible tablets twice daily according to body weights. Each dispersible tablet contains 20mg of artemether/120mg of lumefantrine) and the patients were dosed as follows: 5 -\<15Kg one tablet, 15 - \<25 Kg two tablets, 25 - \<35 Kg three tablets, and ≥35 Kg four tablets at the following dosing intervals: * 0 hour - 1st dose; * 8 hours - 2nd dose; * 24 hours - 3rd dose; * 36 hours - 4th dose; * 48 hours - 5th dose * 60 hours - 6th dose.
Drug: Antimalarials, Artemether + Lumefantrine
The main interventions investigated are pyronaridine-artesunate granules or tablets (Pyramax™) manufactured by Shin Poong Pharmaceuticals, Seoul, Korea. Pyramax granules come in sachets with each containing 60mg of pyronaridine/20mg of artesunate while Pyramax tablets contain 180mg pyronaridine/60mg artesunate.
Also known as: Pyramax™
Artemether-lumefantrine dispersible tablets (Coartem™, Novartis pharma) twice daily according to body weights. Each dispersible tablet of AL contains 20mg of artemether/120mg of lumefantrine).
Also known as: Coartem™, Novartis pharma
PCR-adjusted adequate clinical and parasitological response (ACPR)
Defined as absence of patent parasitaemia, regardless of axillary temperature and without evidence of previous treatment failure up to day 28.
Time frame: Treatment day 3 to 28
Adequate clinical and parasitological response without correction for reinfection
Adequate clinical and parasitological response (ACPR; absence of parasitaemia on day 28 without previously meeting criteria for ETF, LCF, or LPF). Note: ETF: Early treatment failure defined as danger signs or complicated malaria or failure to adequately respond to therapy on days 0-3. LCF: Late clinical failure defined as danger signs or complicated malaria or fever and parasitaemia on days 4-28 without previously meeting criteria for ETF or LPF. LPF: Late parasitological failure defined as asymptomatic parasitaemia on days 7-28 without previously meeting criteria for ETF or LCF.
Time frame: day 28
Parasite clearance time
Time from first dose of ACT until first total and continued disappearance of asexual parasite forms.
Time frame: Treatment day 0 to 28
Fever clearance time
Time from first dose until the first time the body temperature (for those with a raised temperature at enrolment) decrease to below 37.5 degree Celsius and remain so for at least 24 hours.
Time frame: Treatment day 0 to 28
Gametocyte carriage
Proportions of patients with gametocyte at a given point in time.
Time frame: Treatment day 0 to 28
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University of Ibadan