Please use this identifier to cite or link to this item: https://hdl.handle.net/10356/147053
Title: Point-of-Care approaches for meningitis diagnosis in a low-resource setting (Southwestern Uganda) : observational cohort study protocol of the "PI-POC" trial
Authors: Gaudenzi, Giulia
Kumbakumba, Elias
Rasti, Reza
Nanjebe, Deborah
Réu, Pedro
Nyehangane, Dan
Mårtensson, Andreas
Nassejje, Milly
Karlsson, Jens
Mzee, John
Nilsson, Peter
Businge, Stephen
Loh, Edmund
Yap, Boum II
Andersson-Svahn, Helene
Gantelius, Jesper
Mwanga-Amumpaire, Juliet
Alfvén, Tobias
Keywords: Science::Medicine
Issue Date: 2020
Source: Gaudenzi, G., Kumbakumba, E., Rasti, R., Nanjebe, D., Réu, P., Nyehangane, D., Mårtensson, A., Nassejje, M., Karlsson, J., Mzee, J., Nilsson, P., Businge, S., Loh, E., Yap, B. I., Andersson-Svahn, H., Gantelius, J., Mwanga-Amumpaire, J. & Alfvén, T. (2020). Point-of-Care approaches for meningitis diagnosis in a low-resource setting (Southwestern Uganda) : observational cohort study protocol of the "PI-POC" trial. JMIR Research Protocols, 9(11). https://dx.doi.org/10.2196/21430
Journal: JMIR research protocols 
Abstract: Background: A timely differential diagnostic is essential to identify the etiology of central nervous system (CNS) infections in children, in order to facilitate targeted treatment, manage patients, and improve clinical outcome. Objective: The Pediatric Infection-Point-of-Care (PI-POC) trial is investigating novel methods to improve and strengthen the differential diagnostics of suspected childhood CNS infections in low-income health systems such as those in Southwestern Uganda. This will be achieved by evaluating (1) a novel DNA-based diagnostic assay for CNS infections, (2) a commercially available multiplex PCR-based meningitis/encephalitis (ME) panel for clinical use in a facility-limited laboratory setting, (3) proteomics profiling of blood from children with severe CNS infection as compared to outpatient controls with fever yet not severely ill, and (4) Myxovirus resistance protein A (MxA) as a biomarker in blood for viral CNS infection. Further changes in the etiology of childhood CNS infections after the introduction of the pneumococcal conjugate vaccine against Streptococcus pneumoniae will be investigated. In addition, the carriage and invasive rate of Neisseria meningitidis will be recorded and serotyped, and the expression of its major virulence factor (polysaccharide capsule) will be investigated. Methods: The PI-POC trial is a prospective observational study of children including newborns up to 12 years of age with clinical features of CNS infection, and age-/sex-matched outpatient controls with fever yet not severely ill. Participants are recruited at 2 Pediatric clinics in Mbarara, Uganda. Cerebrospinal fluid (for cases only), blood, and nasopharyngeal (NP) swabs (for both cases and controls) sampled at both clinics are analyzed at the Epicentre Research Laboratory through gold-standard methods for CNS infection diagnosis (microscopy, biochemistry, and culture) and a commercially available ME panel for multiplex PCR analyses of the cerebrospinal fluid. An additional blood sample from cases is collected on day 3 after admission. After initial clinical analyses in Mbarara, samples will be transported to Stockholm, Sweden for (1) validation analyses of a novel nucleic acid–based POC test, (2) biomarker research, and (3) serotyping and molecular characterization of S. pneumoniae and N. meningitidis. Results: A pilot study was performed from January to April 2019. The PI-POC trial enrollment of patients begun in April 2019 and will continue until September 2020, to include up to 300 cases and controls. Preliminary results from the PI-POC study are expected by the end of 2020. Conclusions: The findings from the PI-POC study can potentially facilitate rapid etiological diagnosis of CNS infections in low-resource settings and allow for novel methods for determination of the severity of CNS infection in such environment.
URI: https://hdl.handle.net/10356/147053
ISSN: 1929-0748
DOI: 10.2196/21430
Rights: © 2020 The Author(s). Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.11.2020. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
Fulltext Permission: open
Fulltext Availability: With Fulltext
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