Status:
UNKNOWN
Effectiveness and Chemoprevention Efficacy of Implementing Seasonal Malaria Chemoprevention in Karamoja Region, Uganda
Lead Sponsor:
Malaria Consortium
Conditions:
Malaria
Eligibility:
All Genders
3-59 years
Phase:
PHASE4
Brief Summary
To-date, seasonal malaria chemoprevention (SMC) has only been scaled up across the Sahel region of west and central Africa, primarily because of concerns over widespread resistance to sulfadoxine-pyri...
Detailed Description
The study aims to test the effectiveness and chemoprevention efficacy of seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine (SPAQ) and dihydroartemisinin-piperaquine (DP) in the Kar...
Eligibility Criteria
Inclusion
- Children between 3-59 months
- Being resident in the project area
- Afebrile with no other malaria associated symptoms in the past 48 hours or at time of recruitment
- Consent to participate in the study obtained
- Can comply with 3 days DOT of standard SPAQ or DP regimen (day 0-2)
- Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including all dry blood spot and slide collections
Exclusion
- Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours)
- Known allergy to medicine provided
- Receiving a sulfa-based medication for treatment or prophylaxis, including co-trimoxazole (trimethoprim-sulfamethoxazole).
- Individuals receiving azithromycin due to the antimalarial activity of azithromycin.
- Severe malnutrition according to WHO guidelines
- Treatment of uncomplicated malaria with DP in the past 28 days
- HIV positive or ARV use (SPAQ MUST NEVER be used with children taking the antiretroviral efavirenz)
- Chronic illness of any kind
- Recruited in cRCT or any other studies
- Treatment with an ACT in previous 2 weeks.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
6805 Patients enrolled
Trial Details
Trial ID
NCT05323721
Start Date
June 1 2022
End Date
December 1 2023
Last Update
November 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Amudat
Amudat, Karamoja, Uganda