Paediatric Infections Point-Of-Care

Summary

This study aims to identify the aetiology of childhood meningitis in Southwestern Uganda and develop and evaluate new methods for point-of-care diagnosis of childhood meningitis in a low-income setting. A prospective observational study including 600 children aged 0-12 years will be conducted during 1 year in Mbarara, Uganda. We estimate to recruit about 300 children with suspected meningitis (cases), and 300 with non-severe infection age-matched as controls.

Conditions

• Meningitis
• Pediatric Infectious Diseases

Interventions

DIAGNOSTIC_TEST

Multiplex PCR assay for meningitis

CSF from cases to be analysed with a FilmArray ME Panel

DIAGNOSTIC_TEST

Multiplex vertical flow microarrray assay for meningitis

CSF from cases will also undergo analysis with a newly developed prototype for point-of-care diagnostic tool for CNS infections identification. The tool is a DNA-based vertical flow microarray technology printed on paper.

DIAGNOSTIC_TEST

Profiling of blood proteins by multi-analyte Profiling technology

Blood from cases and controls to be analysed using Luminex technology to identify protein profiles associated with severe and non-severe infection. Myxovirus protein A (MxA) will also be analysed by the Luminex assay, to associate MxA levels with severe/non-severe infection.

OTHER

Typing and whole genome sequencing

Pathogenic strains isolated from nasopharyngeal swabs from cases and controls will undergo whole genome sequencing (WGS) and typing .

Sponsors & Collaborators

• Mbarara University of Science and Technology

  collaborator OTHER

• Science for Life Laboratory

  collaborator UNKNOWN

• Epicentre Mbarara Research Center

  collaborator UNKNOWN

• Stockholm South General Hospital

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Elias Kumbakumba, MD · Mbarara University of Science and Technology

• Tobias Alfvén, MD PhD · Karolinska Institutet

Eligibility

Min Age

1 Day

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2020-07-24

Completion

2020-07-24

Countries

• Uganda

Study Locations