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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

786 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-24

Study Completion Date

2015-11-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malaria Malaria,Falciparum Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All students

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.

Screening and treatment

Intervention Type OTHER

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

Interventions

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Screening and treatment

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

Intervention Type OTHER

Other Intervention Names

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mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrine

Eligibility Criteria

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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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes