International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2025
Arterolane and piperaquine Vs. artemether and lumefantrine in uncomplicated malaria: A randomized study in Nigeria.
Клиническое исследование IV фазыEquivalence TrialСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Awodele Olufunsho, Bello Ibrahim Sebutu, Akodu Babatunde Abdulmajeed, Ahmed Abdulakeem Ayanleye, Usman Sikiru, Bolarinwa Rahman Ayodele, Akinyede Akinwumi, Adelabu Hameed Adewale, Akande Emmanuel Oluwatimilehin, Dey Jayanta, Kudrigikar Vinay, Rao P Sameer, Mehta Suyog
Аннотация
OBJECTIVE: To compare the efficacy and safety of Arterolane maleate-Piperaquine phosphate (AMP) and Artemether-lumefantrine (AL) in Nigerian patients with acute, uncomplicated Plasmodium falciparum malaria.
METHODS: This phase IV, randomized, multicenter, open-label, active-controlled study included patients aged 12-65 years with acute symptomatic, uncomplicated P. falciparum malaria. A total of 350 patients were randomized (1:1) to Test group [AMP (150 mg+750 mg) once daily] or Comparator group [AL (80 mg+480 mg) twice daily] for 3 consecutive days. The primary endpoint was polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) on Day 28. Secondary endpoints included PCR-corrected ACPR (Day 42), PCR-uncorrected ACPR (Days 28 and 42), fever clearance time (FCT), and parasite clearance time (PCT).
RESULTS: PCR-corrected ACPR was 100% on Day 28 and sustained till Day 42 in both groups. PCR-uncorrected ACPR rates were comparable in both groups (AMP: 98.2%, AL: 99.4% on Day 28, P = 0.352; AMP: 98.2%, AL: 98.8% on Day 42, P = 0.674). No significant differences in FCT and PCT were observed between the groups. No drug-related adverse events (AEs) or severe AEs were reported.
CONCLUSION: Once-daily dosing of AMP demonstrates comparable efficacy and safety to standard twice-daily dosing of AL in the treatment of uncomplicated P. falciparum malaria.
TRIAL ID: Pan African Clinical Trials Registry - PACTR202305878745601 (prospectively registered on 22nd May 2023), URL: pactr.samrc.ac.za/Search.aspx.
METHODS: This phase IV, randomized, multicenter, open-label, active-controlled study included patients aged 12-65 years with acute symptomatic, uncomplicated P. falciparum malaria. A total of 350 patients were randomized (1:1) to Test group [AMP (150 mg+750 mg) once daily] or Comparator group [AL (80 mg+480 mg) twice daily] for 3 consecutive days. The primary endpoint was polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) on Day 28. Secondary endpoints included PCR-corrected ACPR (Day 42), PCR-uncorrected ACPR (Days 28 and 42), fever clearance time (FCT), and parasite clearance time (PCT).
RESULTS: PCR-corrected ACPR was 100% on Day 28 and sustained till Day 42 in both groups. PCR-uncorrected ACPR rates were comparable in both groups (AMP: 98.2%, AL: 99.4% on Day 28, P = 0.352; AMP: 98.2%, AL: 98.8% on Day 42, P = 0.674). No significant differences in FCT and PCT were observed between the groups. No drug-related adverse events (AEs) or severe AEs were reported.
CONCLUSION: Once-daily dosing of AMP demonstrates comparable efficacy and safety to standard twice-daily dosing of AL in the treatment of uncomplicated P. falciparum malaria.
TRIAL ID: Pan African Clinical Trials Registry - PACTR202305878745601 (prospectively registered on 22nd May 2023), URL: pactr.samrc.ac.za/Search.aspx.
Предметные рубрики MeSH
AdolescentAdultAgedChildFemaleHumansMaleMiddle AgedYoung AdultAntimalarialsArtemether, Lumefantrine Drug CombinationArtemisininsDrug CombinationsEthanolaminesFluorenesHeterocyclic Compounds, 1-RingMalaria, FalciparumNigeriaPeroxidesPlasmodium falciparumQuinolinesSpiro CompoundsTreatment OutcomePiperazines