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Completed

NCT Number: NCT04858087

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

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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Key information

Conditions

Malaria Anemia Hematologic Diseases Hemic and Lymphatic Diseases Infections Malaria, Falciparum Malaria,Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Screening and treatment

Other

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

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

Primary outcomes

  1. P. falciparum infection

    Time frame: 6 weeks after screening

    Any stage Pf infection detected by quantitative polymerase chain reaction (PCR)

  2. P. falciparum gametocyte presence

    Time frame: 6 weeks after screening

    Pfs25 quantitative reverse transcriptase PCR

  3. P. falciparum gametocyte density

    Time frame: 6 weeks after screening

    Pfs25 quantitative reverse transcriptase PCR

Secondary outcomes

  1. Microscopic P. falciparum infection

    Time frame: 6 weeks after screening

    Pf infection detected by microscopy

  2. Anemia

    Time frame: 6 weeks after screening

    Hb measured by Hemocue and categorized using WHO age and gender specific values

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Kamuzu University of Health Sciences
  • Michigan State University
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 26, 2021
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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