Optimization of Seasonal Malaria Chemoprevention (SMC) Delivery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02646410
• Date of registration: 29/12/2015
• Prospective Registration: No
• Primary sponsor: University of Bamako
• Public title: Optimization of Seasonal Malaria Chemoprevention (SMC) Delivery SMC
• Scientific title: Optimal Delivery of Seasonal Malaria Chemoprevention and Its Effects on the Acquisition of Malaria Immunity
• Date of first enrolment: August 2014
• Target sample size: 10000
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02646410
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Mali

Contacts

• Name: Alassane Dicko, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

Age >= 3 months & < 60 months

Exclusion Criteria:

- severe, chronic illness

- known allergy to one of the study drugs (SP or AQ)

- known HIV positive subjects using Cotrimoxazole.



Age minimum: 3 Months
Age maximum: 59 Months
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Anemia

Intervention(s)

Other: DDD+DOT

Other: FPD+DOT

Other: FPD+NDOT

Other: DDD+NDOT

Primary Outcome(s)

Hospital admission [Time Frame: 1, 2, 3, 4 years of the intervention]

Coverage of SMC [Time Frame: 1-5 weeks after last round of SMC in Year1]

Incidence of clinical malaria in Year 2 [Time Frame: up to 4 weeks after the last round of SMC]

Mortality rate [Time Frame: 1, 2, 3, 4 years of the intervention]

Secondary Outcome(s)

moderate anemia [Time Frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC]

Clinical malaria in Year 1 [Time Frame: up to 4 weeks after the last round of SMC]

nutritional status [Time Frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC]

immune response to malaria parasite [Time Frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC]

molecular markers of resistance to SP + AQ [Time Frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC]

malaria parasitemia [Time Frame: one week before the first round of SMC and 4-6 weeks after the last round of SMC]

Secondary ID(s)

2014-61

Source(s) of Monetary Support

Please refer to primary and secondary sponsors