Status:
UNKNOWN
Chemoprevention Efficacy Study Nigeria
Lead Sponsor:
Malaria Consortium
Conditions:
Malaria
Eligibility:
All Genders
3-59 years
Phase:
PHASE4
Brief Summary
The study aims to assess the chemoprevention efficacy of Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) used in standard age-based dosing regimens used in Seasonal Malaria Chemoprevention (SMC) and ...
Detailed Description
The study aims (1) to determine the chemoprevention efficacy of Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) used in standard age-based dosing regimens for Seasonal Malaria Chemoprevention (SMC) i...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Children between 3-59 months.
- Being resident in the research study area.
- Afebrile children 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 regimen.
- 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 criteria
- Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours)
- Known allergy to SPAQ.
- 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
- HIV positive or ARV use (SPAQ MUST NEVER be used with children taking the antiretroviral efavirenz)
- Chronic illness of any kind.
- Treatment with an ACT in previous 2 weeks.
- Previous treatment with SPAQ this malaria season.
Exclusion
Key Trial Info
Start Date :
July 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2024
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05979896
Start Date
July 28 2023
End Date
May 15 2024
Last Update
August 7 2023
Active Locations (1)
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1
Kwara Sentinell Site
Kwara, Nigeria