Study Results
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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COMPLETED
351 participants
OBSERVATIONAL
2019-04-01
2020-07-24
Brief Summary
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Detailed Description
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The bioMérieux FilmArray® ME Panel is an existing multiplexed PCR based system for rapid microbiology analyses of CSF. Even though previous studies have reported good diagnostic accuracy of the FilmArray® system, the studies have mostly been focused on evaluating the system in high-income settings.
This study will do a field evaluation of the diagnostic performance and clinical usability of the FilmArray® ME Panel in a low-income setting in Mbarara, Uganda.
A study by Page et al, conducted 2009-2012 in Mbarara, Uganda, identified the most frequent pathogen causing childhood bacterial meningitis to be Streptococcus pneumoniae. This is also the case on a global level, with the addition of the bacteria Neisseria meningitidis and Haemophilus influenzae type B. However, the Page study did not find a single case of Neisseria meningitidis, which is in contrast to most other reports from low-, middle- and high-income countries. Furthermore, after the finalisation of the Page study, pneumococcal conjugate vaccines were introduced to the Ugandan childhood immunisation program. This study will identify the current aetiology of childhood meningitis and the impact of the pneumococcal conjugate vaccine, in Mbarara, Uganda, and also study the carriage and characteristics of Neisseria meningitis in children in the area.
Myxovirus resistance protein A (MxA) blood levels have been reported to be elevated in children with respiratory tract infections of viral aetiology, as compared to bacterial aetiology. Previous studies have also shown a higher abundance of MxA in viral encephalitis, however this only through histological analyses of post-mortem brain tissue samples.
This study aims to investigate the correlation of blood MxA levels in children with viral, bacterial and malarial meningitis in Mbarara, Uganda by analysing the protein profile and temporal dynamic in blood of children with severe and non-severe infection.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cases with clinical meningitis
Patients aged 0-12 years with suspected CNS infection, at the pediatric clinics at Mbarara Regional Referral Hospital or Holy Innocents Children's Hospital, Mbarara, Uganda.
Multiplex PCR assay for meningitis
CSF from cases to be analysed with a FilmArray ME Panel
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.
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.
Typing and whole genome sequencing
Pathogenic strains isolated from nasopharyngeal swabs from cases and controls will undergo whole genome sequencing (WGS) and typing .
Control subjects
Patients aged 0-12 years, visiting the outpatient pediatric clinics at Mbarara Regional Referral Hospital or Holy Innocents Children's Hospital, Mbarara, Uganda, with fever clinically considered non-severe.
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.
Typing and whole genome sequencing
Pathogenic strains isolated from nasopharyngeal swabs from cases and controls will undergo whole genome sequencing (WGS) and typing .
Interventions
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Multiplex PCR assay for meningitis
CSF from cases to be analysed with a FilmArray ME Panel
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.
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.
Typing and whole genome sequencing
Pathogenic strains isolated from nasopharyngeal swabs from cases and controls will undergo whole genome sequencing (WGS) and typing .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* meet the case or control definition criteria, and where
* informed consent is obtained from the parent or guardian
* No, insufficient or inappropriate CSF sample collection
1 Day
12 Years
ALL
No
Sponsors
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Mbarara University of Science and Technology
OTHER
Science for Life Laboratory
UNKNOWN
Epicentre Mbarara Research Center
UNKNOWN
Stockholm South General Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Tobias Alfvén
Associate Professor
Principal Investigators
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Elias Kumbakumba, MD
Role: PRINCIPAL_INVESTIGATOR
Mbarara University of Science and Technology
Tobias Alfvén, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Holy Innocents Children's Hospital
Mbarara, , Uganda
Mbarara Regional Referral Hospital
Mbarara, , Uganda
Countries
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References
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Rasti R, Kumbakumba E, Nanjebe D, Mlotshwa P, Nassejje M, Mzee J, Businge S, Akankwasa G, Nyehangane D, Gantelius J, Boum Y 2nd, Martensson A, Mwanga-Amumpaire J, Alfven T, Gaudenzi G. Clinical utility of the FilmArray(R) meningitis/encephalitis panel in children with suspected central nervous system infection in a low-resource setting - a prospective study in Southwestern Uganda. BMC Infect Dis. 2025 Mar 22;25(1):396. doi: 10.1186/s12879-025-10732-w.
Gaudenzi G, Kumbakumba E, Rasti R, Nanjebe D, Reu P, Nyehangane D, Martensson A, Nassejje M, Karlsson J, Mzee J, Nilsson P, Businge S, Loh E, Boum Ii Y, Andersson-Svahn H, Gantelius J, Mwanga-Amumpaire J, Alfven T. Point-of-Care Approaches for Meningitis Diagnosis in a Low-Resource Setting (Southwestern Uganda): Observational Cohort Study Protocol of the "PI-POC" Trial. JMIR Res Protoc. 2020 Nov 4;9(11):e21430. doi: 10.2196/21430.
Other Identifiers
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2018/1676-31/1
Identifier Type: -
Identifier Source: org_study_id