NCT06986512

Brief 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, 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

August 14, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

March 11, 2025

Last Update Submit

August 13, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • The size of pathogens

    Measure the size of pathogens

    From enrollment to the end of treatment at 2 weeks

  • scattering intensity of pathogen

    Determine the shape of pathogens through scattering intensity

    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

    From enrollment to the end of treatment at 2 weeks

Interventions

bronchoscopyPROCEDURE

We will perform bronchoscopy and collect bronchoalveolar lavage fluid (BALF)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Suspected or diagnosed patients with pulmonary infection caused by Pseudomonas aeruginosa

You may qualify if:

  • Aged 18 years and above
  • After admission, Pseudomonas aeruginosa was cultured in bronchoalveolar lavage fluid or lower respiratory tract aspirates

You may not qualify if:

  • Age under 18 years old or over 90 years old
  • Pregnancy, lactation period -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 21000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will dynamically and continuously collect bronchoalveolar lavage fluid samples from participants and diagnosed with Pseudomonas aeruginosa infection.

MeSH Terms

Conditions

Pseudomonas Infections

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

May 23, 2025

Study Start

September 1, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

August 14, 2025

Record last verified: 2025-05

Locations