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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

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