Holistic Approach Supporting the Uptake of Innovative Diagnostic Technologies for Respiratory Infections
Recruiting now
Conditions studied: Upper Respiratory Infection, Lower Resp Tract Infection
In brief
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.
Key facts
- Study ID
- NCT07651865
- Run by
- Karolinska Institutet
- People needed
- 2160
- Starts
- 2025-04-07
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2026-06-29
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 6 months
- Presentation with suspected respiratory tract infection and at least two of the following symptoms:
- Fever (axillary temperature ≥37.5°C) or history of fever
- New acute cough episode
- Shortness of breath
- Tachypnoea (fast breathing)
- Loss of smell and/or taste
- Ability to provide written informed consent (or assent with parent/guardian consent for minors)
- For infants (≤1 year), both fever and new acute cough must be present at screening
You may not qualify if…
- 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
- Acute injury, trauma, or poisoning interfering with participation
- Chronic cough lasting >2 weeks, unless tuberculosis is suspected in the LRTI cohort
- Antibiotic use within the previous 2 weeks for participants enrolled in the LRTI cohort (Sub-study 2) only
Where it is running
- Institut Pasteur de Dakar — Dakar, Senegal (enrolling)
- Epicentre Mbarara Research Centre — Mbarara, Uganda (enrolling)
- Armauer Hansen Research Institute (AHRI) — Addis Ababa, Ethiopia
Full record on ClinicalTrials.gov
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