An observational study in Malaria, Malaria,Falciparum and Anemia, sponsored by University of Maryland, Baltimore. Completed. Open to participants aged 5 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by University of Maryland, Baltimore · Observational
A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P. falciparum (Pf) infections in school-age children and determine the impact of the screen-and-treat approach on Pf infection and anemia prevalence among students in two different transmission settings. Investigators aimed to evaluate how frequently malaria rapid diagnostic tests (mRDTs) fail to detect low-parasite-density infections as well as whether low-density infections contribute to the burden and health consequences of Pf infection in school-age children and whether they contain gametocytes, the parasite stage required for transmission from humans to mosquitos.
Students were enrolled in four schools in southern Malawi in the rainy (March-May) and dry season (Sept-Nov) of 2015. 15 students per grade-level (grades 1-8), were invited to participate. Following enrollment, students were evaluated at baseline for screening-and-treatment, and followed-up 1, 2 and 6 weeks later. At each follow-up visit, a blood sample was obtained for microscopy and molecular detection of parasites and students were interviewed about bed net use the night prior, current or recent illness, and use of antimalarial treatment. At the final visit, a mRDT and hemoglobin test were repeated, and parents were interviewed and portable medical records ("health passports") were reviewed to identify intercurrent fever or malaria treatment.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 786 is above the median of 600 across 218 observational studies indexed under Malaria.
Browse Malaria studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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15 students per grade (1 through 8) were randomly sampled in four primary schools
Exclusion Criteria:
All participating students were screened for Pf infection using malaria rapid diagnostic tests (mRDTs) and treated if positive. All were followed 1, 2, and 6 weeks after screening-and-treatment.
Other: Screening and treatment
Students were screened by mRDTs and treated with artemether-lumefantrine if positive
Also known as: mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrine
P. falciparum infection
Any stage Pf infection detected by quantitative polymerase chain reaction (PCR)
Time frame: 6 weeks after screening
P. falciparum gametocyte presence
Pfs25 quantitative reverse transcriptase PCR
Time frame: 6 weeks after screening
P. falciparum gametocyte density
Pfs25 quantitative reverse transcriptase PCR
Time frame: 6 weeks after screening
Microscopic P. falciparum infection
Pf infection detected by microscopy
Time frame: 6 weeks after screening
Anemia
Hb measured by Hemocue and categorized using WHO age and gender specific values
Time frame: 6 weeks after screening
No study locations are listed for this record.
Plan to share: Yes — data will be available via a publicly available database, such as ClinEpiDB
Supporting information: Study protocol
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore