Holistic Approach Supporting the Uptake of Innovative Diagnostic Technologies for Respiratory Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorKarolinska Institutet
About this trial
This observational diagnostic validation study aims to evaluate the clinical performance of novel lateral flow and microfluidic-based technologies for the detection of upper and lower respiratory tract infections in children and adults presenting with respiratory symptoms in Uganda, Ethiopia, and Senegal. The main questions it aims to answer are:
1. whether the novel multiplex lateral flow tests and point-of-care microfluidic platform demonstrate sufficient sensitivity and specificity for detecting respiratory pathogens compared with standard laboratory reference methods, and 2. whether these technologies are feasible and usable in low-resource clinical settings.
Participants presenting with suspected respiratory tract infections as part of routine clinical care will provide respiratory and blood samples for diagnostic testing and biobanking, and demographic and clinical information will be collected during a single study visit. Some adult participants and community stakeholders will also complete surveys or interviews regarding the acceptability of biobanking and diagnostic implementation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 6 months
Fever (axillary temperature ≥37.5°C) or history of fever
New acute cough episode
Shortness of breath
Disqualifiers
Refusal or inability to provide informed consent/assent
Refusal to provide study samples
Severe chronic medical conditions or mental incapacity that, in the opinion of the clinician, would interfere with study participation
Hospitalisation within the previous 2 weeks for reasons unrelated to the current respiratory symptoms
Trial population
The study will enrol symptomatic children aged 6 months to 17 years and adults aged ≥18 years of both sexes presenting to participating hospitals and health centres with suspected upper or lower respiratory tract infections (RTIs). Participants will be recruited in Uganda, Ethiopia, and Senegal from outpatient and inpatient healthcare settings. Eligible participants will present with at least two symptoms consistent with respiratory infection, such as fever, acute cough, shortness of breath, tachypnoea, or loss of smell and/or taste. Participants (or parents/guardians for minors) will provide written informed consent prior to enrolment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Upper respiratory tract infections (URTIs) cohort (sub-study 1)
To determine the diagnostic performance, including sensitivity and specificity of the multi-LFT using a nasopharyngeal (NP) swab, with results interpreted via both visual detection and an Android tablet as a reader.
Time frame
From April 2025 to May 2026Secondary outcomes
1
Lower Respiratory Tract Infections - Point-of-Care Instrument cohort (sub-study 2)
To validate the clinical performance (sensitivity and specificity) of a POC platform that performs pathogen detection (bacteria, fungi) using microfluidic-LAMP isothermal amplification and quantification of host-response biomarkers, using a bead-based immunoassay, by comparing its results to those of reference standard methods (benchtop PCR and ELISA, respectively).
Time frame
April 2025 to May 2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
KTH Royal Institute of Technology
Collaborator
Institut Pasteur, Dakar, Sénégal
Collaborator
Armauer Hansen Research Institute, Ethiopia
Collaborator
Epicentre Mbarara Research Center
Collaborator
Global Access Diagnostics (GADx)
Collaborator
MAST Diagnostica Gmbh
Collaborator
Makerere University
Collaborator
Hahn Schickard
Collaborator
Teesside University
Collaborator
BLUMORPHO SAS
Collaborator
iSTOC OY
Collaborator
University of Freiburg
Collaborator
Stockholm University
Collaborator
Source ClinicalTrials.gov