Malaria Clinical Trial
— INDIE-SMCOfficial title:
Understanding and Maximizing the Community Impact of Antimalarial Treatment (INDIE-SMC)
Seasonal Malaria Chemoprophylaxis (SMC) is a fundamental component of malaria control. The SMC program involves that sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) is given to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. Yet, its efficacy is increasingly below expectations. This study involves an Operational evaluation of a modified existing intervention and its implementation are prepared in direct interaction with the Ministry of Health (MoH) to tailor data collection to local needs. The main questions it aims to answer are: 1. what are the reasons for the continued high infection rates in the SMC-targeted population; 2. what are the implications for transmission of sub-optimal SMC in children less than 5 years old; 3. can the impact of SMC be improved by including older age groups that would both expand the population that experiences direct chemoprophylactic benefits and concurrently reduce transmission to the wider community Researchers will: i) Compare SMC effectiveness as implemented by the national malaria control program and SMC implemented in a research context where all doses are directly observed. ii) Quantify the infectious reservoir and the contribution of different age groups to transmission with conventional SMC (<5 years) and extended SMC (<10 years) iii) Determine the impact of drug resistance and drug absorption on SMC efficacy iv) Understand social barriers and enablers interfering with SMC efficacy and how SMC uptake is related to health equity with special attention to gender inequalities. v) Quantify SMC efficacy decay under programmatic conditions and key drivers of this decay.
Status | Recruiting |
Enrollment | 2470 |
Est. completion date | October 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Months and older |
Eligibility | The study population will be derived from individuals aged 3 months to up to 10 years old eligible for SMC. Inclusion criteria: - Eligible for chemoprevention for SMC as per the current recommendations - Age 3- 59 months for arms i. and ii. - Age 60 months up to 10 years old for arm iii. - Absence of symptomatic falciparum malaria, defined by fever on enrolment - Absence of other non-P. falciparum species on blood film - No evidence of acute severe or chronic disease - Able and willing to comply with the study protocol and follow-up schedule - Parent or guardian provides written, informed consent on behalf of child Exclusion criteria: - Symptoms of malaria (axillary fever = 37.5 °C and/or history of fever in the past 48 hours) - Previous reaction to study drugs / known allergy to study drugs - Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia > 100,000 parasites / µL) - Signs of acute or chronic illness, including hepatitis - The use of other medication (except for paracetamol and/or aspirin) - Presence of severe malnutrition according to WHO's child growth standards |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Groupe de Recherche Action en Santé | Ouagadougou |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Groupe de Recherche Action en Sante, Radboud University Medical Center |
Burkina Faso,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Infectivity to mosquitoes, defined as the percentage of infected mosquitoes, in relation to gametocyte density and plasma drug levels of AQ and DESAQ | This endpoint will assess the infectivity to mosquitoes between intervention arms related to gametocytemia and plasma drug levels. | Up to 10 weeks | |
Other | Size and age-distribution of the infectious reservoir for malaria | This endpoint will assess the likelihood that a mosquito becomes infected with malaria parasites after feeding on a population member (between arm comparison) | Through study completion, an average of 10 months | |
Other | Prevalence of drug resistance markers in infected children aged 3 months-9 years assessed post each round of SMC (between arm comparison) | This endpoint will assess the prevalence of drug resistance markers after each round of SMC. | Through study completion, an average of 10 months | |
Other | Description of perceived social barriers to SMC uptake | This endpoint is designed to understand potential factors that influence SMC uptake and effectiveness | Through study completion, an average of 10 months | |
Other | Quantification of SMC efficacy decay under programmatic conditions | This endpoint will assess the practical realities that result in reduction of SMC coverage. | Through study completion, an average of 10 months | |
Primary | Parasite prevalence by quantitative PCR (qPCR) at the end of the transmission season in age groups targeted by seasonal malaria chemoprevention. | This endpoint will be compared between arms 1 and 2 (in children aged 3-59 months) and arms 2 and arm 3 (in children aged 3 months-9 years). | 4 weeks | |
Secondary | Parasite prevalence by qPCR at the end of the transmission season in all age groups | This endpoint will compare the parasite prevalence in all age groups between intervention arms. | 4 weeks | |
Secondary | Parasite prevalence by microscopy prior to SMC rounds 2, 3 and 4 in SMC-targeted age groups | This endpoint will compare the prevalence by microscopy before SMC rounds (2, 3 and 4) between intervention arms. | 8 weeks | |
Secondary | Rate of re-infection with P. falciparum at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups | This endpoint will assess the rate of malaria reinfection at different time points after the alst round of SMC between intervention arms | 10 weeks | |
Secondary | Gametocyte prevalence by qRT-PCR at weeks 3, 4 and 5 after the last round of SMC, assessed in SMC-targeted age groups | This endpoint will compare the gametocyte prevalence between intervention arms at different time points after the last round of SMC. | 10 weeks | |
Secondary | Gametocyte prevalence by qRT-PCR at the end of the transmission season in all age groups | This endpoint will compare the gametocyte prevalence between intervention arms in all age groups | 8 weeks | |
Secondary | Plasma levels of AQ and DESAQ after the 4th round of SMC in children aged 3 months-9 years | This endpoint will compare the plasma levels of AQ and DESAQ between intervention arms. | 6 weeks |
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