Aspergillosis Detection Via EBC-GM in Ventilated Patients

NCT06333379 | Completed

• 2 other identifiers: SichuanPPHLC042020LY01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bronchoalveolar Lavage Fluid; Sensitivity and Specificity; Critical Illness; Respiration Failure; Respiratory Fungal Infection; Exhaled Breath Condensate; Aspergillosis, Invasive Pulmonary

Keywords

Exhaled breath condensation; Bronchoalvelar lavage fluid; Galactomannan; Invasive Pulmonary Aspergillosis; Non-invasive diagosis

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  Based on samples collected on the same day, followed by 72 hours of observation.

Study Arms (2)

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.

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.

Other: Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF

Interventions

Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF OTHER

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.

IPA group; control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Lin Chen: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 86610072, China

Location

Related Publications (1)

• 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.

  PMID: 38954860 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The investigators collected bronchoalveolar lavage fluid (BALF) and exhaled breath condensate (EBC) specimens from all patients for GM testing. One of the BALF specimens also needed to be sent for culture and macrogenomic sequencing in Invasive Aspertillosis Pneumonia(IPA) group and control group.

MeSH Terms

Conditions

Hypersensitivity; Critical Illness; Respiratory Insufficiency; Invasive Pulmonary Aspergillosis

Interventions

Floors and Floorcoverings

Condition Hierarchy (Ancestors)

Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases

Intervention Hierarchy (Ancestors)

Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Study Officials

• Lin Chen, doctoral

  Sichuan Provincial People's Hospita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 27, 2024
• Study Start: January 2, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 10, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

CN (1)