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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04858087
• Other study ID #: HP-00052129
• Secondary ID: U19AI089683
• Status: Completed
• Start date: March 24, 2015
• Est. completion date: November 13, 2015

Study information

• Verified date: April 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 786
• Est. completion date: November 13, 2015
• Est. primary completion date: November 13, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Malaria
• Malaria, Falciparum
• Malaria,Falciparum

Intervention

Other:
• Screening and treatment
Students were screened by mRDTs and treated with artemether-lumefantrine if positive

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Michigan State University, National Institute of Allergy and Infectious Diseases (NIAID), University of Malawi College of Medicine

References & Publications (1)

Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P. falciparum infection	Any stage Pf infection detected by quantitative polymerase chain reaction (PCR)	6 weeks after screening
Primary	P. falciparum gametocyte presence	Pfs25 quantitative reverse transcriptase PCR	6 weeks after screening
Primary	P. falciparum gametocyte density	Pfs25 quantitative reverse transcriptase PCR	6 weeks after screening
Secondary	Microscopic P. falciparum infection	Pf infection detected by microscopy	6 weeks after screening
Secondary	Anemia	Hb measured by Hemocue and categorized using WHO age and gender specific values	6 weeks after screening