MeningitisPI-POCNCT03900091
Paediatric Infections Point-Of-Care
An observational study of Meningitis and Pediatric Infectious Diseases, run by Karolinska Institutet at 2 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 years
- Conditions the study is for
- Meningitis, Pediatric Infectious Diseases
- What is being tested?
- Multiplex PCR assay for meningitis, Multiplex vertical flow microarrray assay for meningitis and Profiling of blood proteins by multi-analyte Profiling technology
- How many people
- 351 participants
- Where
- 2 sitesUganda
- Study dates
- 1 Apr 2019to 24 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: CASE DEFINITION: Patients aged 0-12 years, with suspected CNS infection understood as, having fever in the past 48 hours (children <9 months may present with any temp)) AND recent onset of any of the following: * Non-traumatic reduced consciousness; in pre-verbals <9 months Blantyre coma score <4; Blantyre coma score <5 for older pre-verbals. In verbal children Glasgow Coma Scale <15 * prostration, hypotonia/hypertonia, unexplained irritability * severe headache * photophobia * neck stiffness or bulging fontanel * seizure(s) * focal neurological signs * age >18 months: positive Kernig or Brudzinski signs * Skin petechiae * Cheyne Stokes CNS infection can be suspected for other reasons CONTROL DEFINITION: Patients aged 0-12 years, visiting the outpatient pediatric clinics with fever and not meeting the case inclusion criteria. For every case, one age-matched control will be sought until included.
Who may be able to join
- Children aged 0 months to 12 years of age, who
- meet the case or control definition criteria, and where
- informed consent is obtained from the parent or guardian
Who cannot join
- all 3 inclusion criteria not met
- No, insufficient or inappropriate CSF sample collection
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Holy Innocents Children's Hospital
Mbarara
Mbarara Regional Referral Hospital
Mbarara
About this study
Official title: Paediatric Infections Point-Of-Care: Point-of-care Approach for Rapid and Easy Meningitis Diagnosis
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.
Read the detailed description
The current gold standard for laboratory diagnostics of suspected childhood meningitis are microbiology culture of CSF and polymerase chain reaction (PCR). However, these methods are expensive, time-consuming, require dedicated facilities and trained professionals, that are often lacking in low-income health systems. Our team has developed a new vertical flow paper printed microarray method for rapid, inexpensive and multiplexed microbiology analysis of cerebrospinal fluid (CSF), with potential for point-of-care use in low-income settings. This study will evaluate the diagnostic accuracy of this newly developed paper printed microarray method.
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
- Meningitis, Pediatric Infectious Diseases
- Being tested
- Multiplex PCR assay for meningitis, Multiplex vertical flow microarrray assay for meningitis, Profiling of blood proteins by multi-analyte Profiling technology, Typing and whole genome sequencing
- Keywords
- Point of care, Diagnostics, Low-income countries, Meningitis, Pediatrics, MxA, FilmArray, Low-cost diagnostics
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex PCR assay for meningitisDiagnostic test
Also called Biomerieux FilmArray ME Panel
CSF from cases to be analysed with a FilmArray ME Panel
Multiplex vertical flow microarrray assay for meningitisDiagnostic test
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 technologyDiagnostic test
Also called Luminex Multi-Analyte Profiling (xMAP)
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 sequencingOther
Pathogenic strains isolated from nasopharyngeal swabs from cases and controls will undergo whole genome sequencing (WGS) and typing .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Multiplex PCR assay for meningitis; Diagnostic Test: Multiplex vertical flow microarrray assay for meningitis; Diagnostic Test: Profiling of blood proteins by multi-analyte Profiling technology; Other: Typing and whole genome sequencing | |
| 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. Receives: Diagnostic Test: Profiling of blood proteins by multi-analyte Profiling technology; Other: Typing and whole genome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of vertical flow microarray printed on paper for pathogen identification in human cerebrospinal fluid samples
The newly developed assay will be evaluated with regards to diagnostic accuracy. For this, results will be compared with those from bacterial culture, PCR and FilmArray analyses of the same samples.
Measured: Patient CSF will be analysed with culture, PCR and FilmArray during ongoing patient management in Mbarara, Uganda. Analyses on frozen patient CSF samples with vertical flow paper printed microarray will be done in Stockholm, Sweden within 1 year.
Secondary outcomes (8)
Protein profile variance between children with severe and non-severe infection
Protein profile (biomarker) concentration (e.g. μg/L) variance in the blood of children with severe infection as compared to those with uncomplicated infection, as well as longitudinal variance in protein profile during the course of severe infection.
Measured: Frozen patient blood samples will be analyzed using Luminex Multiplex Assays in Stockholm, Sweden, within 1 year after sample collection in Mbarara, Uganda.
Variance in concentration of MxA in blood of patients with viral vs. non-viral meningitis and non-severe infection.
Difference in MxA concentration (e.g. μg/L) in peripheral blood of patients with viral/non-viral meningitis and non-severe infection will be studied with the Luminex platform, to identify any feasibility of MxA to be used as a blood biomarker to differentiate between aetiologies of meningitis and to differentiate meningitis to non-severe infection. This in order to assist differential diagnostics in the clinical management of childhood fever.
Measured: MxA concentration measurements will be conducted on the Luminex platform on frozen patient blood samples in Stockholm, Sweden, within a year from sample collection.
Diagnostic performance of the FilmArray ME Panel for meningitis diagnostics in children in a low-income setting
Diagnostic accuracy of the FilmArray® (compared to current gold standard methods PCR and culture) for aetiological diagnosis of CNS infections in children. Sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios will be calculated for the results from FilmArray analyses on patient CSF samples.
Measured: FilmArray analyses on fresh patient CSF samples will be conducted immediately after or within 1 day of sample collection.
Clinical impact of the FilmArray ME Panel on management of childhood meningits in a low-income setting.
Parameteres including time to laboratory confirmed diagnosis, time to treatment initiation, duration of hospital stay (all in hours/days) and patient mortality will be measured for suspected cases of meningitis whose CSF has been analyzed using the FilmArray® ME panel.
Measured: FilmArray analyses on fresh patient CSF samples will be conducted immediately after or within 1 day of sample collection.
Usability of the FilmArray ME Panel for meningitis diagnostics in children in a low-income setting.
A questionnaire will used to gather experiences from health care personnel in Mbarara involved in clinical management of children with suspected meningitis and laboratory personnel in Mbarara conducting FilmArray analyses, in order to study clinical perspectives on the contribution of FilmArray assays to the management of meningitis, in this low-income setting.
Measured: Questionnaires will be handed out and collected from participants continuously during the 1 year duration of patient inclusion.
Mapping of Neisseria meningitidis carriage and prevalence in children in Mbarara, Uganda
Whole genome sequencing and serotyping of any strains of N. meningitidis isolated from nasopharyngeal swabs from included children in Mbarara (cases and controls) will be done to understand the local prevalence of N. meningitidis in severe/non-severely ill children in the district.
Measured: Nasopharyngeal swabs will be collected upon inclusion to the study. Sequencing and serotyping will be done in Stockholm, Sweden, within 1 year after sample collection.
Etiology of childhood meningitis in the Mbarara district, Uganda.
Current aetiology of childhood meningitis in the Mbarara district, Uganda, will be studied through culture, PCR and FilmArray analyses of CSF samples from children with suspected meningitis.
Measured: CSF culture, PCR and FilmArray analyses will be conducted during the 1 year duration of the study, in Mbarara, Uganda.
The impact of pneumococcal conjugate vaccines on aetiology of childhood meningits in the Mbarara district.
Comparison of current (post-vaccination era) to prior (pre-vaccination era) aetiology of childhood meningitis. The pneumococcal vaccine was recently included in the Ugandan childhood immunization program, and just prior to this, the aetiology of childhood meningitis in the Mbarara district was reported by Page et al, finding S. pneumoniae to be the most frequent agent causing bacterial meningitis in the district. Has this changed?
Measured: CSF culture, PCR and FilmArray analyses will be conducted during the 1 year duration of the study, in Mbarara, Uganda.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Apr 2019
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Science for Life Laboratory, Epicentre Mbarara Research Center, Stockholm South General Hospital
- Responsible party
- Principal investigator, Tobias Alfvén, Karolinska Institutet
- Investigators
- Elias Kumbakumba, MD, Principal investigator, Mbarara University of Science and TechnologyTobias Alfvén, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900091
- Sponsor's protocol ID
- 2018/1676-31/1
- Acronym
- PI-POC
- Status last verified
- Dec 2020
- First submitted
- 19 Mar 2019
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40121439Gaudenzi 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.
PubMed 33146628
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Infections Point-Of-Care: Point-of-care Approach for Rapid and Easy Meningitis Diagnosis
- ClinicalTrials.gov ID
- NCT03900091
- Acronym / sponsor ID
- PI-POC / 2018/1676-31/1
- Conditions
- Meningitis, Pediatric Infectious Diseases
- Keywords
- Point of care, Diagnostics, Low-income countries, Meningitis, Pediatrics, MxA, FilmArray, Low-cost diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Science for Life Laboratory, Epicentre Mbarara Research Center, Stockholm South General Hospital
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current gold standard for laboratory diagnostics of suspected childhood meningitis are microbiology culture of CSF and polymerase chain reaction (PCR). However, these methods are expensive, time-consuming, require dedicated facilities and trained professionals, that are often lacking in low-income health systems. Our team has developed a new vertical flow paper printed microarray method for rapid, inexpensive and multiplexed microbiology analysis of cerebrospinal fluid (CSF), with potential for point-of-care use in low-income settings. This study will evaluate the diagnostic accuracy of this newly developed paper printed microarray method.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with clinical meningitis | – | Diagnostic Test: Multiplex PCR assay for meningitis, Diagnostic Test: Multiplex vertical flow microarrray assay for meningitis, Diagnostic Test: Profiling of blood proteins by multi-analyte Profiling technology, Other: Typing and whole genome sequencingPatients 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. |
| Control subjects | – | Diagnostic Test: Profiling of blood proteins by multi-analyte Profiling technology, Other: Typing and whole genome sequencingPatients 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. |
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- CASE DEFINITION: Patients aged 0-12 years, with suspected CNS infection understood as, having fever in the past 48 hours (children <9 months may present with any temp)) AND recent onset of any of the following: * Non-traumatic reduced consciousness; in pre-verbals <9 months Blantyre coma score <4; Blantyre coma score <5 for older pre-verbals. In verbal children Glasgow Coma Scale <15 * prostration, hypotonia/hypertonia, unexplained irritability * severe headache * photophobia * neck stiffness or bulging fontanel * seizure(s) * focal neurological signs * age >18 months: positive Kernig or Brudzinski signs * Skin petechiae * Cheyne Stokes CNS infection can be suspected for other reasons CONTROL DEFINITION: Patients aged 0-12 years, visiting the outpatient pediatric clinics with fever and not meeting the case inclusion criteria. For every case, one age-matched control will be sought until included.
Key inclusion criteria (3 listed)
- Children aged 0 months to 12 years of age, who
- meet the case or control definition criteria, and where
- informed consent is obtained from the parent or guardian
Key exclusion criteria (2 listed)
- all 3 inclusion criteria not met
- No, insufficient or inappropriate CSF sample collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplex PCR assay for meningitisAlso: Biomerieux FilmArray ME PanelCSF from cases to be analysed with a FilmArray ME Panel | Diagnostic test | Cases with clinical meningitis |
| Multiplex vertical flow microarrray assay for meningitisCSF 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 | Cases with clinical meningitis |
| Profiling of blood proteins by multi-analyte Profiling technologyAlso: Luminex Multi-Analyte Profiling (xMAP)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. | Diagnostic test | Cases with clinical meningitis, Control subjects |
| Typing and whole genome sequencingPathogenic strains isolated from nasopharyngeal swabs from cases and controls will undergo whole genome sequencing (WGS) and typing . | Other | Cases with clinical meningitis, Control subjects |
Primary outcome
Diagnostic accuracy of vertical flow microarray printed on paper for pathogen identification in human cerebrospinal fluid samples
Time frame: Patient CSF will be analysed with culture, PCR and FilmArray during ongoing patient management in Mbarara, Uganda. Analyses on frozen patient CSF samples with vertical flow paper printed microarray will be done in Stockholm, Sweden within 1 year.
The newly developed assay will be evaluated with regards to diagnostic accuracy. For this, results will be compared with those from bacterial culture, PCR and FilmArray analyses of the same samples.
8 secondary outcomes
Protein profile variance between children with severe and non-severe infection
Time frame: Frozen patient blood samples will be analyzed using Luminex Multiplex Assays in Stockholm, Sweden, within 1 year after sample collection in Mbarara, Uganda.
Variance in concentration of MxA in blood of patients with viral vs. non-viral meningitis and non-severe infection.
Time frame: MxA concentration measurements will be conducted on the Luminex platform on frozen patient blood samples in Stockholm, Sweden, within a year from sample collection.
Diagnostic performance of the FilmArray ME Panel for meningitis diagnostics in children in a low-income setting
Time frame: FilmArray analyses on fresh patient CSF samples will be conducted immediately after or within 1 day of sample collection.
Clinical impact of the FilmArray ME Panel on management of childhood meningits in a low-income setting.
Time frame: FilmArray analyses on fresh patient CSF samples will be conducted immediately after or within 1 day of sample collection.
Usability of the FilmArray ME Panel for meningitis diagnostics in children in a low-income setting.
Time frame: Questionnaires will be handed out and collected from participants continuously during the 1 year duration of patient inclusion.
Mapping of Neisseria meningitidis carriage and prevalence in children in Mbarara, Uganda
Time frame: Nasopharyngeal swabs will be collected upon inclusion to the study. Sequencing and serotyping will be done in Stockholm, Sweden, within 1 year after sample collection.
Etiology of childhood meningitis in the Mbarara district, Uganda.
Time frame: CSF culture, PCR and FilmArray analyses will be conducted during the 1 year duration of the study, in Mbarara, Uganda.
The impact of pneumococcal conjugate vaccines on aetiology of childhood meningits in the Mbarara district.
Time frame: CSF culture, PCR and FilmArray analyses will be conducted during the 1 year duration of the study, in Mbarara, Uganda.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 40121439Rasti 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.
- Derived from this study: PubMed 33146628Gaudenzi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias Kumbakumba, MD principal investigator
Mbarara University of Science and Technology
Tobias Alfvén, MD PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis and Pediatric Infectious Diseases, run by Karolinska Institutet at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of vertical flow microarray printed on paper for pathogen identification in human cerebrospinal fluid samples (time frame: Patient CSF will be analysed with culture, PCR and FilmArray during ongoing patient management in Mbarara, Uganda. Analyses on frozen patient CSF samples with vertical flow paper printed microarray will be done in Stockholm, Sweden within 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.