Rapid DetectionNCT06986512
Rapid Detection of Pseudomonas Aeruginosa in Bronchoalveolar Lavage Fluid Using Label-free Single-particle Imaging Technology and Assessment of Post-treatment Efficacy in Patients With Pseudomonas Aeruginosa Infection
An observational study of Rapid Detection and Pseudomonas Aeruginosa Infection, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The aim of this study is to observe specimens of bronchoalveolar lavage fluid from patients using a reflection enhanced dark-field scattering microscopy. By observing parameters such as the size, morphology, scattering intensity, and movement speed of pathogens, combined with the clinical characteristics of patients… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rapid Detection, Pseudomonas Aeruginosa Infection
- What is being tested?
- bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Nov 2025
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected or diagnosed patients with pulmonary infection caused by Pseudomonas aeruginosa
Who may be able to join
- Aged 18 years and above
- After admission, Pseudomonas aeruginosa was cultured in bronchoalveolar lavage fluid or lower respiratory tract aspirates
Who cannot join
- Age under 18 years old or over 90 years old
- Pregnancy, lactation period -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 21000
Wenkui Sun, +86 13914742215, sunwenkui@njmu.edu.cn
About this study
The aim of this study is to observe specimens of bronchoalveolar lavage fluid from patients using a reflection enhanced dark-field scattering microscopy. By observing parameters such as the size, morphology, scattering intensity, and movement speed of pathogens, combined with the clinical characteristics of patients, a rapid diagnosis of Pseudomonas aeruginosa infection can be made. At the same time, the bronchoalveolar lavage fluid samples of patients infected with Pseudomonas aeruginosa before and after treatment were compared, and the quantity and vitality of Pseudomonas aeruginosa were observed to judge the efficacy of antibiotics.
- Conditions
- Rapid Detection, Pseudomonas Aeruginosa Infection
- Being tested
- bronchoscopy
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopyProcedure or surgery
We will perform bronchoscopy and collect bronchoalveolar lavage fluid (BALF)
What is being measured
The primary outcome is the main question the study is designed to answer.
The size of pathogens
Measure the size of pathogens
Measured: From enrollment to the end of treatment at 2 weeks
scattering intensity of pathogen
Determine the shape of pathogens through scattering intensity
Measured: From enrollment to the end of treatment at 2 weeks
movement speed of pathogens
Measure the movement speed of pathogens, such as flagellates like Pseudomonas aeruginosa, which have a fast movement speed
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid DetectionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986512
- Sponsor's protocol ID
- 2024-SR-806
- Status last verified
- May 2025
- First submitted
- 11 Mar 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Detection of Pseudomonas Aeruginosa in Bronchoalveolar Lavage Fluid Using Label-free Single-particle Imaging Technology and Assessment of Post-treatment Efficacy in Patients With Pseudomonas Aeruginosa Infection
- ClinicalTrials.gov ID
- NCT06986512
- Acronym / sponsor ID
- 2024-SR-806
- Conditions
- Rapid Detection, Pseudomonas Aeruginosa Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to observe specimens of bronchoalveolar lavage fluid from patients using a reflection enhanced dark-field scattering microscopy. By observing parameters such as the size, morphology, scattering intensity, and movement speed of pathogens, combined with the clinical characteristics of patients, a rapid diagnosis of Pseudomonas aeruginosa infection can be made. At the same time, the bronchoalveolar lavage fluid samples of patients infected with Pseudomonas aeruginosa before and after treatment were compared, and the quantity and vitality of Pseudomonas aeruginosa were observed to judge the efficacy of antibiotics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected or diagnosed patients with pulmonary infection caused by Pseudomonas aeruginosa
Key inclusion criteria (2 listed)
- Aged 18 years and above
- After admission, Pseudomonas aeruginosa was cultured in bronchoalveolar lavage fluid or lower respiratory tract aspirates
Key exclusion criteria (2 listed)
- Age under 18 years old or over 90 years old
- Pregnancy, lactation period -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopyWe will perform bronchoscopy and collect bronchoalveolar lavage fluid (BALF) | Procedure or surgery | – |
Primary outcome
The size of pathogens
Time frame: From enrollment to the end of treatment at 2 weeks
Measure the size of pathogens
scattering intensity of pathogen
Time frame: From enrollment to the end of treatment at 2 weeks
Determine the shape of pathogens through scattering intensity
movement speed of pathogens
Time frame: From enrollment to the end of treatment at 2 weeks
Measure the movement speed of pathogens, such as flagellates like Pseudomonas aeruginosa, which have a fast movement speed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rapid Detection and Pseudomonas Aeruginosa Infection, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenkui Sun, Dr (+86 13914742215, sunwenkui@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The size of pathogens (time frame: From enrollment to the end of treatment at 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.