Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa

Duke Clinical Research Institute0 个研究点目标入组 246 人开始时间: 2017年6月22日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Age greater than 12 months and less than 10 years at enrollment;
•Current attendance at or willingness to attend the study SCA clinic at HBCH;
•Residence in either Homa Bay County or the Rongo or Awendo sub-counties of Migori County;
•Confirmed hemoglobin genotype of HbSS by electrophoresis, HPLC, or PCR;
•No immediate, apparent, or reported plans to relocate residence from Homa Bay County or the Rongo or Awendo sub-counties of Migori County in the next 2 years;
•Ability to take oral medication and be willing to adhere to the medication regimen or caregiver willingness to give the medical regimen as prescribed;
•Ability and willingness of parent or legally authorized representative (LAR) to give informed consent;
•Assent of child in those > 7 years.

•Taking routine antimalarial prophylaxis for another indication (including co-trimoxazole for HIV infection);
•Temperature of ¿ 37.5C at screening or history of objective or subjective fever in the preceding 24 hours during screening;
•Known allergy or sensitivity to sulfadoxine, pyrimethamine, amodiaquine, proguanil, dihydroartemisinin, piperaquine, artemether, lumefantrine, pencillin (if under 5 years old), or derivatives of these compounds;
•Known chronic medical condition other than SCA (i.e. malignancy, HIV) requiring frequent medical attention;
•Currently participating in another clinical research study, or having participated in one in the prior 30 days;
•Living in the same household as a previously-enrolled study participant;
•Chronic use of medications known to prolong the QT interval in children;
•Fridericia's corrected QT interval (QTcF) interval > 450msec.

发起方