Dihydroartemisinin-piperaquine versus artesunate-amodiaquine for treatment of malaria infection in pregnancy in Ghana: an open-label, randomised, non-inferiority trial.
Trop Med Int Health
; 22(8): 1043-1052, 2017 08.
Article
em En
| MEDLINE
| ID: mdl-28556586
OBJECTIVE: To determine whether dihydroartemisinin-piperaquine (DHA-PPQ) is non-inferior to artesunate-amodiaquine (ASAQ) for treating uncomplicated malaria infection in pregnancy. METHODS: A total of 417 second/ third trimester pregnant women with confirmed asymptomatic Plasmodium falciparum parasitaemia were randomised to receive DHA-PPQ or ASAQ over 3 days. Women were followed up on days 1, 2, 3, 7, 14, 28 and 42 after treatment start and at delivery for parasitological, haematological, birth outcomes and at 6-week post-partum to ascertain the health status of the babies. Parasitological efficacy (PE) by days 28 and 42 were co-primary outcomes. Analysis was per-protocol (PP) and modified intention-to-treat (ITT). Non-inferiority was declared if the two-sided 95% confidence interval for PE at the endpoints excluded 5% lower efficacy for DHA-PPQ. Secondary outcomes were assessed for superiority. RESULTS: In PP analysis, PE was 91.6% for DHA-PPQ and 89.3% for ASAQ by day 28 and 89.0% and 86.5%, respectively, by day 42. DHA-PPQ was non-inferior to ASAQ with respect to uncorrected PE [adjusted difference by day 28 (DHA-PPQ-ASAQ); 3.5% (95%CI: -1.5, 8.5); and day 42: 3.9% (95%CI: -2.7, 10.4)]. ITT analysis gave similar results. PCR to distinguish recrudescence and reinfection was unsuccessful. DHA-PPQ recipients had fewer adverse events of vomiting, dizziness, and general weakness compared to ASAQ. Both drugs were well-tolerated, and there was no excess of adverse birth outcomes. CONCLUSION: DHA-PPQ was non-inferior to ASAQ for treatment of malaria infection during pregnancy. No safety concerns were identified. Our findings contribute to growing evidence that DHA-PPQ is useful for control of malaria in pregnancy.
Palavras-chave
Dihidroartemisinina-piperaquina; Dihydroartemisinin-piperaquine; Dihydroartémisinine-pipéraquine; Ghana; artesunate-amodiaquine; artesunato-amodiaquina; artésunate-amodiaquine; efficacité; efficacy; eficacia; ensayo de no-inferioridad; malaria en el embarazo; malaria in pregnancy; non-inferiority trial; paludisme pendant la grossesse; safety; seguridad; sécurité; tolerabilidad; tolerability; tolérance; traitement; tratamiento; treatment; étude de non-infériorité
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Complicações Infecciosas na Gravidez
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Quinolinas
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Artemisininas
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Antimaláricos
Tipo de estudo:
Clinical_trials
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Guideline
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Prognostic_studies
Limite:
Adolescent
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Adult
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Female
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Humans
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Pregnancy
Idioma:
En
Revista:
Trop Med Int Health
Assunto da revista:
MEDICINA TROPICAL
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SAUDE PUBLICA
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Gana