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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
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This study will assess the performance of two novel breath collection devices and their subsequent detection of respiratory pathogens compared to sputum samples in patients with lower respiratory tract infections.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sputum collection for molecular analysis | Procedure | Sputum collection to be used with syndromic multiplex PCR testing | ||
| Breath and cough collection for molecular analysis | Device | Breath and cough collection with two proprietary devices to be used with syndromic multiplex PCR testing |
| Measure | Description | Time Frame |
|---|---|---|
| Pathogen Concordance | Overall percent agreement, negative percent agreement, and positive percent agreement between syndromic respiratory multiplex PCR results from breath samples and sputum samples. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Assess the usability of the breath collection devices and sampling procedures by gathering user feedback from patients using a multiple choice questionnaire. Ease-of-use questions will be assessed using a 5-point difficulty rating system. Additionally, the investigators will assess the proportion of participants able to complete the breath collections without any deviations. | 2 days after sample collection |
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Inclusion Criteria:
Able to understand the scope of the study and provide written informed consent
Age >18 years
Speaking German or English
Health status (assessed by study personnel at local site) well enough to use the breath collection devices
Willing to provide all three study samples (sputum and two breath samples) required for the study
Clinical diagnosis of a lower respiratory tract infection (LRTI) defined as:
(i) New infiltrate (chest X-ray, ultrasound, or CT scan), and (ii) at least one clinical symptom suggestive of LRTI (fever ≥38°C, chills, new or worsening cough, new or worsening sputum production, new or worsening dyspnea, tachypnoea, chest pain)
Exclusion Criteria:
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Adults aged 18 and older admitted to the hospital with a clinical diagnosis of lower respiratory tract infection.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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| Expanded user feedback | A subset of patients and clinicians will be observed during the breath collection process. The investigators will gather the proportion of participants making errors during breath collections and documenting any common difficulties. User feedback data from a subset of patients and clinicians will be gathered via semi-structured interviews. Data will be assessed qualitatively for reported acceptability and user preferences. | 2 days after sample collection |
| Rates of indeterminate breath results | Proportion of breath samples with invalid and/or indeterminate syndromic respiratory multiplex PCR results | 6 months |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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