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Clinical Trials/PACTR201707002371165
PACTR201707002371165
Recruiting
未知

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

Duke Clinical Research Institute0 sites246 target enrollmentJune 22, 2017
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ConditionsMalaria

Overview

Phase
未知
Intervention
Not specified
Conditions
Malaria
Sponsor
Duke Clinical Research Institute
Enrollment
246
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 22, 2017
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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