Malaria Clinical Trial
— BF-IPTscOfficial title:
Clinical Trial to Evaluate Efficacy and Safety of Sulfadoxine/Pyrimethamine-Amodiaquine and Dihydroartemsinin-Piperaquine Plus Ivermectin Administered Monthly as Intermittent Preventive Treatment in School-aged Children in Burkina Faso
This will be an open label cluster randomized study with two active intervention and one control arm. A cluster will be defined as a selected village. One district implementing seasonal malaria chemoprevention (SMC) will be selected, and six villages will be randomly selected in this district. These six villages will be randomly allocated to each of the three study arms; 1) Arm 1 will receive IPTsc with sulphadoxine-pyrimethamine plus amodiaquine (SPAQ); and 2) Arm 2 will receive dihydroartemisinin-piperaquine (DP) plus Ivermectin (IVM), all given monthly during the transmission season and 3) Control Arm which will have standard malaria control measures including case management and vector control measures as applicable.
Status | Recruiting |
Enrollment | 13000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 15 Years |
Eligibility | Inclusion Criteria: - Resident in the study area and willing to remain there for the study duration - Age > or = 5 and < 15 years - Willing to provide biological samples as requested during the study period - Provision of informed consent by parents/guardians - Provision of assent from children aged 12 to 15 years. Exclusion Criteria: - Any serious illness or medical situation that could interfere with follow-up - Inability to take study medication - History of known allergy or contraindication to study drugs - History of cardiac disorders or prolonged QT syndrome - Current use of drugs known to prolong QT interval - Participating in another research project. |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Malaria Consortium | Ouagadougou |
Lead Sponsor | Collaborator |
---|---|
Malaria Consortium |
Burkina Faso,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of symptomatic malaria in children of the target age group by microscopy and molecular methods. | prevalence of clinical malaria in the different study arms | 6 months | |
Secondary | Prevalence of asymptomatic malaria | prevalence of asymptomatic parasitemia in the different study arms | 6 months | |
Secondary | Prevalence of anemia | prevalence of anemia in the different study arms | 6 months | |
Secondary | Prevalence of gametocytes determined by microscopy. | prevalence of gametocytes in the different study arms | 6 months | |
Secondary | Prevalence of antimalarial drug resistance markers | prevalence of antimalarial drug resistance markers in the different study arms | 6 months | |
Secondary | Acceptability of the two IPTsc approaches | Acceptability of the two IPTsc approaches by the community. | 6 months | |
Secondary | Cost-effectiveness analysis of IPTsc with SPAQ and DP plus IVM from a provider perspective | cost-effectiveness of the two IPTsc approaches | 6 months |
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