Bronchoalveolar Lavage FluidNCT06333379
Aspergillosis Detection Via EBC-GM in Ventilated Patients
An observational study of Bronchoalveolar Lavage Fluid and Sensitivity and Specificity, run by Lin Chen at 1 site in China.
Trial summary
Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bronchoalveolar Lavage Fluid, Sensitivity and Specificity, Critical Illness
- What is being tested?
- Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2023to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators at Sichuan Provincial Hospital study mechanically ventilated adults for Invasive Pulmonary Aspergillosis (IPA) risks. They classify participants into IPA and control groups. IPA patients meet EORTC/MSG criteria, showing new lung lesions, positive Aspergillus cultures in LRT, positive galactomannan in BALF, and supporting BALF NGS evidence. The control group includes ventilated patients without Aspergillus, confirmed by negative cultures and NGS in BALF. The study aims to assess EBC-GM's diagnostic accuracy for IPA, comparing it with BALF-GM for early, non-invasive detection.
Who may be able to join
- Age: Between 18 and 85 years old. Antifungal Medication Use: Participants who have not used any antifungal medications within the three months prior to enrollment.
- Mechanical Ventilation Status: Patients who have been undergoing mechanical ventilation treatment for more than three days.
Who cannot join
- Inadequate Clinical Data: Inability to provide reliable diagnostic measurements or insufficient clinical information.
- Early Mortality: Patients who die within the first three days of ICU (Intensive Care Unit) admission or during the initial phase of the study.
- Pregnancy: To avoid potential confounding effects on immune function and the composition of EBC (Exhaled Breath Condensate), pregnant women are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Detection of Aspergillosis in Ventilated Patients: Galactomannan Analysis in Exhaled Breath
Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. This study proposes a non-invasive, innovative approach utilizing galactomannan (GM) analysis in Exhaled Breath Condensate (EBC) for early IPA detection.
Objective: To evaluate the diagnostic accuracy of measuring GM levels in EBC for detecting IPA in mechanically ventilated patients, comparing it against the conventional Bronchoalveolar Lavage Fluid (BALF)-GM measurements.
Read more
Methods: A clinical trial will be conducted with 75 mechanically ventilated patients suspected of having IPA. The study will compare the effectiveness of EBC-GM levels against BALF-GM levels in diagnosing IPA, focusing on sensitivity, specificity, and diagnostic accuracy. The novel, self-designed EBC collection device will facilitate the safe and efficient collection of EBC from patients.
Expected Outcomes:
Validation of EBC-GM Diagnostic Accuracy: Anticipate demonstrating that EBC-GM levels provide a comparable diagnostic accuracy to BALF-GM, establishing a non-invasive, safer alternative for IPA detection.
Implementation of a Non-Invasive Diagnostic Tool: The study aims to introduce a non-invasive diagnostic approach that can potentially replace more risky, invasive methods, improving patient care in ICUs.
Contribution to Clinical Practice: By providing a new method for early and safer detection of IPA, the study is expected to influence clinical guidelines and practices in the management of critically ill, ventilated patients.
Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures.
Read the detailed description
Research Proposal: Advancing the Diagnosis of Invasive Pulmonary Aspergillosis through Exhaled Breath Condensate Analysis in Ventilated Patients Background: Invasive Pulmonary Aspergillosis (IPA) remains a formidable challenge in the management of critically ill, immunocompromised patients, especially those requiring mechanical ventilation in Intensive Care Units (ICUs). The high morbidity and mortality rates associated with IPA underscore the urgent need for early and accurate diagnostic methods. Traditional diagnostic approaches, though effective, are invasive and pose significant risks to already vulnerable patients. This study introduces a novel, non-invasive diagnostic methodology by measuring galactomannan (GM) levels in Exhaled Breath Condensate (EBC), potentially revolutionizing the early detection of IPA.
Objective: To evaluate the effectiveness of a non-invasive diagnostic approach by analyzing galactomannan levels in exhaled breath condensate (EBC) for detecting Invasive Pulmonary Aspergillosis (IPA) in mechanically ventilated ICU patients.
Methods:
Study Design: A prospective clinical trial involving 75 mechanically ventilated patients suspected of having IPA within the Medical Intensive Care Unit (MICU) of a tertiary hospital.
Data Collection: Utilizing a self-designed EBC collection device, EBC samples will be collected from participants and analyzed for GM levels. These will be compared to Bronchoalveolar Lavage Fluid (BALF) GM levels, considered the current gold standard in IPA diagnostics.
Analytical Approach: The study will focus on assessing the diagnostic accuracy of EBC-GM measurements by determining sensitivity, specificity, and overall concordance with BALF-GM levels. The potential enhancement of diagnostic precision with the inclusion of cytokine measurements will also be explored.
Innovation: By leveraging a cutting-edge EBC collection device, this research aims to bypass the complications associated with invasive diagnostic procedures, offering a safer, more patient-friendly alternative. This innovative approach has the potential to significantly impact clinical practices in ICU settings by facilitating early and accurate IPA diagnosis without the need for bronchoscopy.
Expected Outcomes:
Diagnostic Performance: Investigators anticipate demonstrating that EBC-GM levels provide a reliable, non-invasive marker for IPA, with diagnostic accuracy comparable to BALF-GM measurements.
Clinical Impact: The successful validation of EBC-GM as a diagnostic tool for IPA will offer a significant advancement in the management of critically ill patients, reducing the need for invasive procedures and associated risks.
Guideline Integration: Findings from this study are expected to support the integration of EBC-GM analysis into clinical guidelines as a recommended diagnostic approach for IPA in mechanically ventilated patients.
Significance: This research has the potential to transform IPA diagnostics in ICU settings, promoting a shift towards non-invasive, risk-free methods that can lead to earlier detection and improved patient outcomes. By minimizing invasive diagnostic interventions, the study aims to enhance the safety and efficacy of IPA management in critically ill populations.
Ethics and Dissemination: The study adheres to the highest ethical standards, with approval from the institutional review board ensuring the protection and well-being of participants. Results will be actively disseminated through peer-reviewed journals and conference presentations, contributing to global efforts in improving ICU patient care in the context of fungal infections.
- Conditions
- Bronchoalveolar Lavage Fluid, Sensitivity and Specificity, Critical Illness, Respiration Failure, Respiratory Fungal Infection, Exhaled Breath Condensate
- Being tested
- Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF
- Keywords
- Exhaled breath condensation, Bronchoalvelar lavage fluid, Galactomannan, Invasive Pulmonary Aspergillosis, Non-invasive diagosis
- Medical subject headings
- Hypersensitivity, Critical Illness, Respiratory Insufficiency, Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALFOther
Investigators tested EBC-GM levels and BALF-GM levels in patients with confirmed IPA to compare the diagnostic value of EBC-GM versus BALF-GM.
| Study group | Role | What they receive |
|---|---|---|
| IPA group | Investigators enrolled patients who meet diagnostic criteria for IPA according to EORTC/MSG: new exudative lung lesions unresponsive to antimicrobial therapy; positive Aspergillus on LRT and/or BALF microscopy cultures, positive BALF GM and positive BALF NGS results for Aspergillus. Investigators will test and compare the EBC-GM and BALF-GM levels in these patients. Receives: Other: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF | |
| control group | Investigators enrolled patients who were mechanically ventilated patients without Aspergillus infection or colonization. BALF and EBC samples from the same patients were collected less than 4 hours apart, and BALF samples were used for NGS and microbiological cultures. Investigators will test and compare the EBC-GM and BALF-GM levels in these patients. Receives: Other: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of EBC-GM vs. BALF-GM
The diagnostic accuracy of Galactomannan (EBC-GM) levels in Exhaled Breath Condensate vs. Bronchoalveolar Lavage Fluid (BALF-GM) levels was measured by Receiver Operating Characteristic (ROC) area under the curve (AUC) assessment. Accuracy of Galactomannan (BALF-GM) levels in the diagnosis of Invasive Pulmonary Aspergillosis (IPA).
Measured: EBC and BALF samples were collected simultaneously on the day of patient admission.
EBC-GM levels:
Evaluate sensitivity and specificity in differentiating patients with IPA from mechanically ventilated patients with non-aspergillosis infections, and determining the critical value of EBC-GM in the diagnosis of IPA.
Measured: The stability of the patients' vital signs was observed within 72 hours to assess the diagnostic accuracy of EBC-GM and BALF-GM.
Secondary outcomes (1)
Correlation between EBC-GM and BALF-GM levels
To assess the correlation between EBC-GM levels and BALF-GM levels in mechanically ventilated IPA patients.
Measured: Based on samples collected on the same day, followed by 72 hours of observation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start2 Jan 2023
- Primary completion30 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchoalveolar Lavage FluidStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Chen, Sichuan Provincial People's Hospital
- Investigators
- Lin Chen, doctoral, Principal investigator, Sichuan Provincial People's Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333379
- Sponsor's protocol ID
- SichuanPPHLC04
- Other IDs
- 2020LY01
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study tests a non-invasive method for detecting Invasive Aspergillosis (IPA) in ICU patients using ventilators. By analyzing galactomannan in exhaled breath, we aim to identify IPA without invasive procedures. Phase 1 involves testing a new breath collection device on rats. Phase 2 applies this device to 75 ICU patients, comparing results with traditional lung fluid tests. Approval from an ethics committee ensures patient safety. Successful outcomes could lead to safer IPA diagnosis, enhancing treatment and reducing risks associated with current methods.
Publications
Tang X, Yang L, Zhang R, Fang H, Tang H, Xie Q, Wang H, Chen L, Yang Y. Non-invasive detection of Aspergillosis in ventilated patients: Galactomannan analysis in exhaled breath. Diagn Microbiol Infect Dis. 2024 Sep;110(1):116420. doi: 10.1016/j.diagmicrobio.2024.116420. Epub 2024 Jun 29.
PubMed 38954860
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Detection of Aspergillosis in Ventilated Patients: Galactomannan Analysis in Exhaled Breath
- ClinicalTrials.gov ID
- NCT06333379
- Acronym / sponsor ID
- SichuanPPHLC04
- Conditions
- Bronchoalveolar Lavage Fluid, Sensitivity and Specificity, Critical Illness, Respiration Failure, Respiratory Fungal Infection, Exhaled Breath Condensate
- Keywords
- Exhaled breath condensation, Bronchoalvelar lavage fluid, Galactomannan, Invasive Pulmonary Aspergillosis, Non-invasive diagosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lin ChenUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 27 Mar 2024 (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.
Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. This study proposes a non-invasive, innovative approach utilizing galactomannan (GM) analysis in Exhaled Breath Condensate (EBC) for early IPA detection.
Objective: To evaluate the diagnostic accuracy of measuring GM levels in EBC for detecting IPA in mechanically ventilated patients, comparing it against the conventional Bronchoalveolar Lavage Fluid (BALF)-GM measurements.
Methods: A clinical trial will be conducted with 75 mechanically ventilated patients suspected of having IPA. The study will compare the effectiveness of EBC-GM levels against BALF-GM levels in diagnosing IPA, focusing on sensitivity, specificity, and diagnostic accuracy. The novel, self-designed EBC collection device will facilitate the safe and efficient collection of EBC from patients.
Expected Outcomes:
Validation of EBC-GM Diagnostic Accuracy: Anticipate demonstrating that EBC-GM levels provide a comparable diagnostic accuracy to BALF-GM, establishing a non-invasive, safer alternative for IPA detection.
Implementation of a Non-Invasive Diagnostic Tool: The study aims to introduce a non-invasive diagnostic approach that can potentially replace more risky, invasive methods, improving patient care in ICUs.
Contribution to Clinical Practice: By providing a new method for early and safer detection of IPA, the study is expected to influence clinical guidelines and practices in the management of critically ill, ventilated patients.
Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures.
Detailed description
Research Proposal: Advancing the Diagnosis of Invasive Pulmonary Aspergillosis through Exhaled Breath Condensate Analysis in Ventilated Patients Background: Invasive Pulmonary Aspergillosis (IPA) remains a formidable challenge in the management of critically ill, immunocompromised patients, especially those requiring mechanical ventilation in Intensive Care Units (ICUs). The high morbidity and mortality rates associated with IPA underscore the urgent need for early and accurate diagnostic methods. Traditional diagnostic approaches, though effective, are invasive and pose significant risks to already vulnerable patients. This study introduces a novel, non-invasive diagnostic methodology by measuring galactomannan (GM) levels in Exhaled Breath Condensate (EBC), potentially revolutionizing the early detection of IPA.
Objective: To evaluate the effectiveness of a non-invasive diagnostic approach by analyzing galactomannan levels in exhaled breath condensate (EBC) for detecting Invasive Pulmonary Aspergillosis (IPA) in mechanically ventilated ICU patients.
Methods:
Study Design: A prospective clinical trial involving 75 mechanically ventilated patients suspected of having IPA within the Medical Intensive Care Unit (MICU) of a tertiary hospital.
Data Collection: Utilizing a self-designed EBC collection device, EBC samples will be collected from participants and analyzed for GM levels. These will be compared to Bronchoalveolar Lavage Fluid (BALF) GM levels, considered the current gold standard in IPA diagnostics.
Analytical Approach: The study will focus on assessing the diagnostic accuracy of EBC-GM measurements by determining sensitivity, specificity, and overall concordance with BALF-GM levels. The potential enhancement of diagnostic precision with the inclusion of cytokine measurements will also be explored.
Innovation: By leveraging a cutting-edge EBC collection device, this research aims to bypass the complications associated with invasive diagnostic procedures, offering a safer, more patient-friendly alternative. This innovative approach has the potential to significantly impact clinical practices in ICU settings by facilitating early and accurate IPA diagnosis without the need for bronchoscopy.
Expected Outcomes:
Diagnostic Performance: Investigators anticipate demonstrating that EBC-GM levels provide a reliable, non-invasive marker for IPA, with diagnostic accuracy comparable to BALF-GM measurements.
Clinical Impact: The successful validation of EBC-GM as a diagnostic tool for IPA will offer a significant advancement in the management of critically ill patients, reducing the need for invasive procedures and associated risks.
Guideline Integration: Findings from this study are expected to support the integration of EBC-GM analysis into clinical guidelines as a recommended diagnostic approach for IPA in mechanically ventilated patients.
Significance: This research has the potential to transform IPA diagnostics in ICU settings, promoting a shift towards non-invasive, risk-free methods that can lead to earlier detection and improved patient outcomes. By minimizing invasive diagnostic interventions, the study aims to enhance the safety and efficacy of IPA management in critically ill populations.
Ethics and Dissemination: The study adheres to the highest ethical standards, with approval from the institutional review board ensuring the protection and well-being of participants. Results will be actively disseminated through peer-reviewed journals and conference presentations, contributing to global efforts in improving ICU patient care in the context of fungal infections.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPA group | – | Other: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALFInvestigators enrolled patients who meet diagnostic criteria for IPA according to EORTC/MSG: new exudative lung lesions unresponsive to antimicrobial therapy; positive Aspergillus on LRT and/or BALF microscopy cultures, positive BALF GM and positive BALF NGS results for Aspergillus. Investigators will test and compare the EBC-GM and BALF-GM levels in these patients. |
| control group | – | Other: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALFInvestigators enrolled patients who were mechanically ventilated patients without Aspergillus infection or colonization. BALF and EBC samples from the same patients were collected less than 4 hours apart, and BALF samples were used for NGS and microbiological cultures. Investigators will test and compare the EBC-GM and BALF-GM levels in these patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators at Sichuan Provincial Hospital study mechanically ventilated adults for Invasive Pulmonary Aspergillosis (IPA) risks. They classify participants into IPA and control groups. IPA patients meet EORTC/MSG criteria, showing new lung lesions, positive Aspergillus cultures in LRT, positive galactomannan in BALF, and supporting BALF NGS evidence. The control group includes ventilated patients without Aspergillus, confirmed by negative cultures and NGS in BALF. The study aims to assess EBC-GM's diagnostic accuracy for IPA, comparing it with BALF-GM for early, non-invasive detection.
Key inclusion criteria (2 listed)
- Age: Between 18 and 85 years old. Antifungal Medication Use: Participants who have not used any antifungal medications within the three months prior to enrollment.
- Mechanical Ventilation Status: Patients who have been undergoing mechanical ventilation treatment for more than three days.
Key exclusion criteria (3 listed)
- Inadequate Clinical Data: Inability to provide reliable diagnostic measurements or insufficient clinical information.
- Early Mortality: Patients who die within the first three days of ICU (Intensive Care Unit) admission or during the initial phase of the study.
- Pregnancy: To avoid potential confounding effects on immune function and the composition of EBC (Exhaled Breath Condensate), pregnant women are excluded.
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 |
|---|---|---|
| Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALFInvestigators tested EBC-GM levels and BALF-GM levels in patients with confirmed IPA to compare the diagnostic value of EBC-GM versus BALF-GM. | Other | IPA group, control group |
Primary outcome
Diagnostic accuracy of EBC-GM vs. BALF-GM
Time frame: EBC and BALF samples were collected simultaneously on the day of patient admission.
The diagnostic accuracy of Galactomannan (EBC-GM) levels in Exhaled Breath Condensate vs. Bronchoalveolar Lavage Fluid (BALF-GM) levels was measured by Receiver Operating Characteristic (ROC) area under the curve (AUC) assessment. Accuracy of Galactomannan (BALF-GM) levels in the diagnosis of Invasive Pulmonary Aspergillosis (IPA).
EBC-GM levels:
Time frame: The stability of the patients' vital signs was observed within 72 hours to assess the diagnostic accuracy of EBC-GM and BALF-GM.
Evaluate sensitivity and specificity in differentiating patients with IPA from mechanically ventilated patients with non-aspergillosis infections, and determining the critical value of EBC-GM in the diagnosis of IPA.
1 secondary outcome
Correlation between EBC-GM and BALF-GM levels
Time frame: Based on samples collected on the same day, followed by 72 hours of observation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 38954860Tang X, Yang L, Zhang R, Fang H, Tang H, Xie Q, Wang H, Chen L, Yang Y. Non-invasive detection of Aspergillosis in ventilated patients: Galactomannan analysis in exhaled breath. Diagn Microbiol Infect Dis. 2024 Sep;110(1):116420. doi: 10.1016/j.diagmicrobio.2024.116420. Epub 2024 Jun 29.
- Individual participant dataSharing planned: Undecided. This study tests a non-invasive method for detecting Invasive Aspergillosis (IPA) in ICU patients using ventilators. By analyzing galactomannan in exhaled breath, we aim to identify IPA without invasive procedures. Phase 1 involves testing a new breath collection device on rats. Phase 2 applies this device to 75 ICU patients, comparing results with traditional lung fluid tests. Approval from an ethics committee ensures patient safety. Successful outcomes could lead to safer IPA diagnosis, enhancing treatment and reducing risks associated with current methods.
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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. This study is not recruiting at the moment.
Lin Chen, doctoral principal investigator
Sichuan Provincial People's Hospita
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 Bronchoalveolar Lavage Fluid and Sensitivity and Specificity, run by Lin Chen 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 3 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: finished, as of the sponsor's last update on 27 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of EBC-GM vs. BALF-GM (time frame: EBC and BALF samples were collected simultaneously on the day of patient admission.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333379, which also lists 1 linked publication.
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 27 Mar 2024.