Status:
ACTIVE_NOT_RECRUITING
Targeted Antimalarial Drug Administration for Seasonal Migrant Populations in Amhara Region, Ethiopia
Lead Sponsor:
PATH
Collaborating Sponsors:
Federal Minstry of Health of Ethiopia
Conditions:
Plasmodium Falciparum
Malaria
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess the effectiveness, feasibility, and acceptability of targeted drug administration for seasonal migrant populations in Metema District, Amhara Region, Ethiopia
Detailed Description
A cluster randomized controlled trial will be used to evaluate the effectiveness, feasibility, and acceptability of targeted antimalarial drug administration (TDA) for seasonal migrant farmworkers in ...
Eligibility Criteria
Inclusion
- At the time of the study, be a seasonal farm worker at one of the selected farm sites in Metema district
- Available and willingness to participate in the study and provide consent (or parental/guardian consent and asset in the case of minors)
Exclusion
- Severe illness (will be referred for care)
- Inability to provide informed consent
- Age 14-17 years old and not having a parent/guardian at the farm who can provide consent
- Age \<14 years old
- Additional exclusion criteria for the intervention group:
- Having received an antimalarial drug within the last 2 weeks
- Having any of the contraindications to receiving DP:
- History of cardiac rhythm disturbances, bradycardia, or heart failure
- Concomitant treatment with drugs that prolong the QT interval (fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron, etc.) or drugs containing any of the following: flecainide, metoprolol, imipramine, amitriptyline, clomipramine
- Known allergic reactions to DP or other artemisinin derivatives
- Pregnancy
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
10350 Patients enrolled
Trial Details
Trial ID
NCT06516042
Start Date
August 21 2024
End Date
July 1 2025
Last Update
May 6 2025
Active Locations (1)
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1
Delello Farm Sites
Gonder, Metema District, Ethiopia