An observational study in Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in Uganda. Open to participants aged 6 Months to 99 Years. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Background:
Objectives:
Eligibility:
Design:
Malaria is a leading cause of morbidity and mortality in Uganda, accounting for 25-40 percent of all outpatient visits at health facilities, 20 percent of hospital admissions, and 9-14 percent of inpatient deaths. Malaria is meso- to holoendemic in Rakai, southwestern Uganda and children under 10 years, pregnant women and HIVinfected individuals bear the greatest burden of disease. Substantial progress has been made in malaria vaccine development and vaccine trials will be conducted over the coming years. The design of these trials will be contingent on understanding the epidemiology of malaria and disease burden in different epidemic settings.
This study will determine the epidemiology of malaria infection in children and adolescents/adults by conducting surveillance in approximately 320 households selected from two of the 10 clusters under the Rakai Community Cohort Study (RCCS). Monthly visits will be made to randomly selected households during a one year surveillance period. Visit procedures include: structured interview/questionnaire of the primary care giver or legal guardian of the child; clinical and laboratory assessment of each child aged 6 months up to 10 years and the primary care giver; and clinical and laboratory assessment of one additional randomly selected adolescent/adult resident of the household. The study team will track usage of health clinic or hospital services within the district in order to link medical records for study participants. This community-based surveillance study will be linked to a separate facility-based surveillance study in health clinics/hospitals servicing the selected communities. This study will enhance the investigators understanding of the epidemiology of pediatric and adult malaria infection in Rakai district in preparation for future malaria vaccine trials. Investigators will be able to estimate the incidence of uncomplicated and severe malaria in children and adults. This protocol will also investigate the prevalence and association of sickle cell trait, xlinked glucose-6-phosphatase dehydrogenase deficiency and hemoglobinopathies (Hemoglobin C) and their associations with severe malaria among children and adults.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 1,650 is above the median of 600 across 218 observational studies indexed under Malaria.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
1600 participants in approximately 320 households.@@@N=1700
Child aged 6 months to less than 10 years, primary care giver of an enrolled child, or an adolescent/adult resident in a household of an enrolled child.
EXCLUSION CRITERIA:
Episodes of uncomplicated and severe clinical malaria per year in children and adults.
to assess the epidemiology of malaria infection among children aged 6months-1year and adults living in the same household with children in Rakai district
Time frame: 1 year
Malaria rates (episodes/per year) in individuals and communities and by seasonality. Clinical episodes will be determined using RDT among febrile participants.
to estimate the proportion of participants from the household surveillance that seek care for malaria in health facilities
Time frame: 1 year
Determine the rates of asymptomatic parasitemia among afebrileparticipants (determined by malaria smears and PCR).
to coordinate the community based surveillance with a facility based surveillance in health clinics servicing the selected communities
Time frame: 1 year
The prevalence of enlarged palpable spleen (splenomegaly) in children
to investigate the prevalence of sickle cell trait,glucose-6 phosphate dehydrogenase deficiency and hemoglobinopathies and their relationship to severe clinical malaria per year in children and adults.
Time frame: 1 year
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)