Clinical trial

Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Cameroon: The Plus Project

Name
PLUS-27988-CAM
Description
The Plus Project will assess the impact, operational feasibility, efficacy, effectiveness, and cost-effectiveness of PMC. Specifically, the impact evaluation will involve monitoring a passive cohort of all children in the study area reporting all doses of SP received and the number of confirmed cases of malaria and anaemia, as well as a prospective active cohort of children who will have seven home visits over an 18-month period. The total number of participants is expected to be approximately 2,080 children in the areas served by 35 health centres in Cameroon. The results of this study will allow direct evaluation of the protective efficacy of PMC on malaria incidence, severe anaemia, and malaria mortality.
Trial arms
Trial start
2023-07-19
Estimated PCD
2025-01-01
Trial end
2025-07-01
Status
Recruiting
Treatment
Sulfadoxine pyrimethamine
Sulfadoxine-pyrimethamine paediatric formulation (250mg/12.5mg) dispersable tablets (Macleods Pharmaceuticals Ltd)
Arms:
Active cohort control, Active cohort intervention
Size
2080
Primary endpoint
Incidence of malaria infection and clinical malaria
18 months
Eligibility criteria
Inclusion Criteria: * Reside in Soa (intervention) or Mbankomo (control) health districts. * Agree to take part in the census. * Aged 6-9 months at the time of enrolment. Exclusion Criteria: * Parent/caregiver refused to participate in the cohort. * Parent/caregiver did not give informed consent.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 2080, 'type': 'ESTIMATED'}}
Updated at
2024-02-05

1 organization

1 product

2 indications

Indication
Anaemia
Indication
Malaria