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Dihydroartemisinin-piperaquine versus artesunate-amodiaquine for treatment of malaria infection in pregnancy in Ghana: an open-label, randomised, non-inferiority trial.
Osarfo, Joseph; Tagbor, Harry; Cairns, Matthew; Alifrangis, Michael; Magnussen, Pascal.
Afiliação
  • Osarfo J; Ghana Health Service, Effiduase District Hospital, Effiduase, Ashanti Region, Ghana.
  • Tagbor H; School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
  • Cairns M; School of Medicine, University of Health and Allied Sciences, Ho, Ghana.
  • Alifrangis M; MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.
  • Magnussen P; Centre for Medical Parasitology, Department of Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark.
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Complicações Infecciosas na Gravidez / Quinolinas / Artemisininas / Antimaláricos Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Adolescent / Adult / Female / Humans / Pregnancy Idioma: En Revista: Trop Med Int Health Assunto da revista: MEDICINA TROPICAL / SAUDE PUBLICA Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Gana

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Complicações Infecciosas na Gravidez / Quinolinas / Artemisininas / Antimaláricos Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Adolescent / Adult / Female / Humans / Pregnancy Idioma: En Revista: Trop Med Int Health Assunto da revista: MEDICINA TROPICAL / SAUDE PUBLICA Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Gana