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

Not Applicable

Recruiting

• Conditions: Malaria

• Registration Number: PACTR201707002371165
• Lead Sponsor: Duke Clinical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RDT-positive P falciparum malaria

Secondary Outcome Measures

Name	Time	Method
Sickle-cell pain crises;Severe malaria ;All-cause hospitalizations;Packed red blood cell transfusions;Acute chest syndrome;All-cause death