In vivo efficacy and safety of artemether-lumefantrine and amodiaquine-artesunate for uncomplicated Plasmodium falciparum malaria in Mozambique, 2018
Malar. j. (Online)
; 20(1): 1-12, out 2, 2021. ilus, graf, mapa
Artículo
en Inglés
| AIM (África), RSDM
| ID: biblio-1532088
Biblioteca responsable:
MZ1.1
RESUMEN
Artemisinin-based combination therapy (ACT) has been the recommended first-line treatment for uncomplicated malaria in Mozambique since 2006, with artemether-lumefantrine (AL) and amodiaquine-artesunate (AS-AQ) as the first choice. To assess efficacy of currently used ACT, an in vivo therapeutic efficacy study was conducted. Methods:
The study was conducted in four sentinel sites Montepuez, Moatize, Mopeia and Massinga. Patients between 6 and 59 months old with uncomplicated Plasmodium falciparum malaria (2000-200,000 parasites/µl) were enrolled between February and September of 2018, assigned to either an AL or AS-AQ treatment arm, and monitored for 28 days. A Bayesian algorithm was applied to differentiate recrudescence from new infection using genotyping data of seven neutral microsatellites. Uncorrected and PCR-corrected efficacy results at day 28 were calculated.Results:
Totals of 368 and 273 patients were enrolled in the AL and AS-AQ arms, respectively. Of these, 9.5% (35/368) and 5.1% (14/273) were lost to follow-up in the AL and AS-AQ arms, respectively. There were 48 and 3 recurrent malaria infections (late clinical and late parasitological failures) in the AL and AS-AQ arms, respectively. The day 28 uncorrected efficacy was 85.6% (95% confidence interval (CI) 81.3-89.2%) for AL and 98.8% (95% CI 96.7-99.8%) for AS-AQ, whereas day 28 PCR-corrected efficacy was 97.9% (95% CI 95.6-99.2%) for AL and 99.6% (95% CI 97.9-100%) for AS-AQ. Molecular testing confirmed that 87.4% (42/48) and 33.3% (1/3) of participants with a recurrent malaria infection in the AL and AS-AQ arms were new infections; an expected finding in a high malaria transmission area. Adverse events were documented in less than 2% of participants for both drugs.Conclusion:
Both AL and AS-AQ have therapeutic efficacies well above the 90% WHO recommended threshold and remain well-tolerated in Mozambique. Routine monitoring of therapeutic efficacy should continue to ensure the treatments remain efficacious. Trial registration Clinicaltrials.gov
Texto completo:
Disponible
Colección:
Bases de datos nacionales
/
MZ
Contexto en salud:
Enfermedades Desatendidas
Problema de salud:
Malária
/
Enfermedades Desatendidas
Base de datos:
AIM (África)
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RSDM
Asunto principal:
Malaria Falciparum
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Antimaláricos
Límite:
Adulto
/
Humanos
País/Región como asunto:
Africa
Idioma:
Inglés
Revista:
Malar. j. (Online)
Año:
2021
Tipo del documento:
Artículo
Institución/País de afiliación:
1Centro de Investigação em Saúde de Manhiça (CISM)/MZ
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Centro de Investigação em Saúde de Manhiça (CISM)/MZ
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Instituto Nacional de Saúde (INS), Ministério da Saúde/MZ
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Malaria Branch, Centers for Disease Control and Prevention/US
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Malaria Branch, Centers for Disease Control and Prevention, Atlanta/US
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Programa Nacional de Controlo da Malária, Ministério da Saúde/MZ
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United States President's Malaria Initiative, Centers for Disease Control and Prevention/MZ
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United States President's Malaria Initiative, United States Agency for International Development/MZ
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World Health Organization, WHO Country Office Maputo/MZ