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NCT05192265
Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine
Phase 2, PHASE3 trial testing Antimalarials, pyronaridine-artesunate in Malaria Fever in 172 participants. Completed in 23 December 2020.
23 December 2020
Quick facts
| Lead sponsor | University of Ibadan |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 172 |
| Start date | 20 May 2019 |
| Primary completion | 23 December 2020 |
| Estimated completion | 23 December 2020 |
| Sites | 1 location across Nigeria |
Drugs / interventions tested
- Antimalarials, pyronaridine-artesunate — full drug profile →
- Antimalarials, Artemether + Lumefantrine — full drug profile →
Conditions studied
- Malaria Fever — all drugs for Malaria Fever →
- Plasmodium Falciparum Malaria — all drugs for Plasmodium Falciparum Malaria →
- Uncomplicated Malaria — all drugs for Uncomplicated Malaria →
Sponsor
University of Ibadan
Who can join
Adults 3 Months to 144 Months, any sex, with Malaria Fever or Plasmodium Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and safety of pyronaridine-artesunate versus artemether-lumefantrine in the treatment of acute uncomplicated malaria in children in South-West Nigeria: an open-labelled randomized controlled trial.
Falade CO, Orimadegun AE, Olusola FI, Michael OS, et al · · 2023 · cited 12× · PMID 37179349 · DOI 10.1186/s12936-023-04574-7 -
Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine in the Treatment of Acute Uncomplicated Malaria in Children in South-West Nigeria: An open- labelled randomized controlled trial
Falade CO, Orimadegun AE, Olusola FI, Michael OS, et al · · 2022 · DOI 10.21203/rs.3.rs-1664143/v1
Verify or expand the search:
- PubMed search for NCT05192265
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05192265 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Ibadan
- Last refreshed: 7 April 2022
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing