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Malawi International Center of Excellence in Malaria Research School-based Cohort

Epidemiology of Malaria in Malawi: Human Hosts and Parasites in Three Districts Part 2: Cross-sectional Surveillance (School-based Cohorts)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04858087
Enrollment
786
Registered
2021-04-26
Start date
2015-03-24
Completion date
2015-11-13
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Malaria, Malaria,Falciparum

Keywords

cohort, screen and treat, artemether-lumefantrine

Brief summary

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.

Detailed description

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.

Interventions

OTHERScreening and treatment

Students were screened by mRDTs and treated with artemether-lumefantrine if positive

Sponsors

Kamuzu University of Health Sciences
CollaboratorOTHER
Michigan State University
CollaboratorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

* Randomly selected student at a participating school

Exclusion criteria

* Parent or guardian not available for consent * Age \<5 or \>= 16 years * Known allergy or adverse reaction to lumefantrine-artemether * Child will not attend this school during the time of the survey * For the dry season survey (Sept-Oct 2015), participants in the rainy season survey (April-May 2015)

Design outcomes

Primary

MeasureTime frameDescription
P. falciparum infection6 weeks after screeningAny stage Pf infection detected by quantitative polymerase chain reaction (PCR)
P. falciparum gametocyte presence6 weeks after screeningPfs25 quantitative reverse transcriptase PCR
P. falciparum gametocyte density6 weeks after screeningPfs25 quantitative reverse transcriptase PCR

Secondary

MeasureTime frameDescription
Microscopic P. falciparum infection6 weeks after screeningPf infection detected by microscopy
Anemia6 weeks after screeningHb measured by Hemocue and categorized using WHO age and gender specific values

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026