Condition: Upper Respiratory Infection · Lower Resp Tract Infection · Sponsor: Karolinska Institutet
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.
This description comes directly from the study's public registry record.
Devanshi Pandit · +44 (0)1234 780020 · Devanshi.Pandit@globalaccessdx.com
Giulia Gaudenzi, PhD · +46 76 3446161 · giulia.gaudenzi@ki.se
Always discuss trial participation with your own doctor first.
| Armauer Hansen Research Institute (AHRI) | Addis Ababa, Ethiopia | Completed |
| Institut Pasteur de Dakar | Dakar, Senegal | Recruiting |
| Epicentre Mbarara Research Centre | Mbarara, Uganda | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07651865