Assessing new breath collection devices for detecting respiratory infections
Novel Exhaled Breath Aerosol Collection Devices in Patients with Lower Respiratory Tract Infection - a Performance and Acceptability Study (Acronym: AeroCAP)
Avelo AG · NCT06668883
This study tests two new breath collection devices to see if they can effectively detect respiratory infections in patients with lower respiratory tract infections compared to traditional sputum samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Avelo AG (industry) |
| Locations | 1 site (Basel) |
| Trial ID | NCT06668883 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the performance of two innovative breath collection devices in detecting respiratory pathogens in patients diagnosed with lower respiratory tract infections (LRTI). Participants will provide both sputum samples and breath samples for molecular analysis to compare the effectiveness of these new devices against traditional sputum collection methods. The study aims to determine the acceptability and reliability of these devices in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are German speakers and have a clinical diagnosis of a lower respiratory tract infection.
Not a fit: Patients with known cystic fibrosis, bronchiectasis, or those critically ill may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient and less invasive methods for diagnosing lower respiratory tract infections.
How similar studies have performed: While the approach of using breath collection devices is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to understand the scope of the study and provide written informed consent * Age \>18 years * Speaking German * 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: * Patients for whom the collection of all three study specimens within 24 hours of initiating antibiotic treatment is not feasible * Patients with known cystic fibrosis or bronchiectasis * Critically ill patients at the discretion of the investigator * Patients on oxygen supplementation with a face mask, high-flow-oxygen, non-invasive or mechanical ventilation; oxygen supplementation via nasal cannula will be permitted. * Patients with proven acute pulmonary embolism * Patients with best supportive care * Patients with severe hypoxemia (SpO2 \<88%) despite oxygen supplementation * Hospitalization within the last 14 days prior to admission
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Elena Reipold, MD, PhD
- Email: elena.reipold@avelolife.com
- Phone: +41 43 588 33 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pneumonia, Lower Respiratory Tract Infection, Respiratory Tract Infections, Communicable Diseases, Infections, Breath