Therapeutic Effectiveness of Artemether-Lumefantrine or Artesunate-Pyronaridine Plus Single Dose Primaquine for the Treatment of Uncomplicated Plasmodium falciparum and Chloroquine or Artesunate-Pyronaridine Plus 14 Days Primaquine for Uncomplicated Plasmodium vivax.

ICAP at Columbia University0 个研究点目标入组 402 人开始时间: 2021年8月31日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Those living within 20 km of the catchment of the health facility with a
•traceable address or phone contact number
•Volunteer to give their address or phone number and willing to not travel
•for the duration of the study
•Volunteer to comply with the study protocol, visit schedule, or get traced in
•case defaulted
•Age = 18 years
•Slide-confirmed infection with Pf, with parasitemia of 500-100,000 asexual
•forms/µl or slide confirmed infection with Pv with > 250 asexual forms/µl
•For the gametocyte clearance and mosquito feeding endpoints, patients with microscopy-detected gametocytes prior to treatment will be eligible to be enrolled
•Axillary temperature = 37.5º C or history of fever during the previous 24 or
•48 hours for Pf and Pv infection, respectively
•Ability to swallow oral medication

•General danger signs or symptoms of severe malaria
•Mixed Plasmodium infection
•Severe anemia, defined as hemoglobin (Hb) < 7 g/dl
•Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, COVID-19, severe diarrhea with dehydration)
•Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
•Positive pregnancy test or breastfeeding
•Refusal to take a pregnancy test for women of child-bearing age (defined as 18–49 years old or menstruating)
•History of hypersensitivity to study or rescue medication in this study
•Taking regular medication which may interfere with antimalarial pharmacokinetics or efficacy

发起方

ICAP at Columbia University