Clinical and molecular epidemiology of Plasmodium falciparum malaria in the Brazilian Amazon basin: implications for the national malaria control program

Instituto Nacional de Infectologia Evandro Chagas0 个研究点开始时间: 2021年9月23日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Inclusion criteria
•Male or women, > 18 years old;
•Acute malaria not complicated by P. falciparum confirmed by thick drop with asexual forms of P. falciparum;
•Parasitic density between 500-100,000 / uL of blood at the time of screening;
•Axillary > 37.5 ° C or history of fever in the last 24 hours;
•Informed written consent;
•Ability to swallow oral medication;
•Willingness and ability to meet the study schedule for the duration of the study.
•Inclusion criteria
•Man or woman, regardless of age;
•Symptomatic malaria falciparum confirmed by (i) positive thick gout with asexual forms of P. falciparum; or (ii) rapid test (RDT) based on LDH, or by (iii) polymerase chain reaction (PCR), HRP2-based AND (iv) HRP2 based RDT;
•Axillary temperature > 37.5 °C or history of fever in the last 24 hours;
•Informed consent in writing;
•Ability and willingness to comply with the study protocols (for the duration of the study and meet the study visit schedule.

•Exclusion criteria
•Presence of general signs of danger / complicated falciparum malaria, according to who 2015 definitions;
•Hematocrit <25% or hemoglobin <8 g/dL at screening;
•Mixed infection or mono-infection with another Plasmodium species detected by microscopy;
•Presence of febrile conditions due to diseases other than malaria (measles, acute infection of the lower respiratory tract, severe diarrhea with dehydration);
•Presence of known underlying chronic or serious diseases (e.g.: heart, kidney, liver, HIV/AIDS) diseases
•For women of childbearing age [18-45 years]: positive pregnancy test or breastfeeding;
•Receipt of antimalarial drugs in the previous 48 hours;
•History of known allergy or contraindication to ASMQ;
•Unable to perform the pregnancy test;
•Previous splenectomy;
•Exclusion criteria
•Have been included in the study previously (Arm II);
•Have not been tested with HRP2-based RDT;
•Refuse the collection of the biological samples.

发起方

Instituto Nacional de Infectologia Evandro Chagas