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NCT Number: NCT06668883

Novel Exhaled Breath Aerosol Collection Devices in Patients With Lower Respiratory Tract Infection - a Performance and Acceptability Study

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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Key information

Conditions

Pneumonia Communicable Diseases Disease Attributes Infections Lower Respiratory Tract Infection (LRTI) Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients for whom the collection of all three study specimens within 48 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

Treatment and study plan

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

Primary outcomes

  1. Pathogen Concordance

    Time frame: 6 months

    Overall percent agreement, negative percent agreement, and positive percent agreement between syndromic respiratory multiplex PCR results from breath samples and sputum samples.

Secondary outcomes

  1. Usability

    Time frame: 2 days after sample collection

    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. Expanded user feedback

    Time frame: 2 days after sample collection

    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.

  3. Rates of indeterminate breath results

    Time frame: 6 months

    Proportion of breath samples with invalid and/or indeterminate syndromic respiratory multiplex PCR results

Sponsors and collaborators

Lead sponsor

Avelo AG

Industry

Collaborators

  • University Hospital, Basel, Switzerland

Registry information

Official study title

Novel Exhaled Breath Aerosol Collection Devices in Patients With Lower Respiratory Tract Infection - a Performance and Acceptability Study (Acronym: AeroCAP)

Acronym: AeroCAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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