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Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo
Bu çalışma, Demokratik Kongo Cumhuriyeti'nde sıtma (malaria) tedavisinde kullanılan artemisinin bazlı kombinasyon tedavilerinin etkinliğini ve güvenliğini değerlendirmektedir. Çalışmaya, komplikasyonsuz Plasmodium falciparum sıtması olan 6-59 aylık çocuklar alınmıştır. Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * children aged 6 to 59 months * axillary temperature ≥ 37.5 °C or history of fever during the 24 h before recruitment * monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL * ability to swallow oral medication * ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule * informed consent from a parent/guardian * absence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO (2000) * absence of severe malnutrition according to WHO child growth standards * absence of febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal or hepatic diseases, HIV/AIDS) * absence of regular medication, which might interfere with antimalarial pharmacokinetics * absence of history of hypersensitivity reactions or contraindication to any medicine being tested or used as alternative treatment Exclusion Criteria: * presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO * body weight \< 5kg * hemoglobin level \< 5g/ dL * mixed or monoinfection with another Plasmodium species detected by microscopy * presence of severe malnutrition * presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS) * regular medication, which may interfere with antimalarial pharmacokinetics; * history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)