Bronchoscopic Score for Prediction of Herpes Simplex-virus Type 1 (HSV-1) Reactivation
Study Details
Study Description
Brief Summary
Tracheobronchial reactivation of HSV-1 is a common finding in critically ill patients and is associated with longer intensive care unit (ICU) stay and mechanical ventilation. At present it is unclear whether the presence of HSV-1 reactivation can be predicted by the clinical phenotype. In the present study, the performance of a bronchoscopic score of tracheobronchial inflammation for prediction of tracheobronchial HSV-1 reactivation is investigated
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Critically ill adult patients having a first diagnostic or therapeutic bronchoscopy are included. A standardized bronchoscopic score (values from 0 to 6) is assessed by an experienced ICU physician.
The score compounds are mucosal redness, mucosal swelling and vulnerability on contact. Compounds are quantified as "none" = 0, "some, disseminated" = 1, or "profound, ubiquitous" = 2 and added.
HSV-1 reactivation is detected by quantitative polymerase chain reaction (PCR) analysis of HSV-1-DNA from standardized bronchoalveolar lavage fluid.
In addition, HSV-1-DNA from blood and markers of immunocompetence (lymphocyte subtype count, monocyte count and Human Leukocyte Antigen - DR isotype (HLA-DR) expression, immunoglobulins) are measured for secondary analyses.
Study Design
Outcome Measures
Primary Outcome Measures
- Bronchoscopic score for prediction of tracheobronchial HSV-1 reactivation [at study inclusion]
The score has values from 0 to 6, and for the primary analyses, HSV-1 reactivation is used as a binary variable (yes vs. no) dependent on the presence vs. absence of HSV-1-DNA in bronchoalveolar fluid. Sensitivity, specificity, positive and negative predictive values as well as best cut-off score values for prediction will be calculated
Secondary Outcome Measures
- Correlation of the bronchoscopic score value with quantitative tracheobronchial HSV-1-DNA load [day of study inclusion]
- Correlation of the bronchoscopic score value with quantitative blood HSV-1-DNA load [day of study inclusion]
- 3. Correlation of tracheobronchial and blood HSV-1-DNA load with markers of immunosuppression (lymphocyte count, lymphocyte subgroups, monocyte count, monocyte HLA-DR expression, immunoglobulin concentration) [day of study inclusion]
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Adult patients (age ≥18 years) 2. Indication for bronchoscopy during intensive care unit stay 3. Written informed consent
Exclusion Criteria:
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- Solid organ transplantation 2. Present coronavirus disease 2019 (COVID-19) infection 3. Previous bronchoscopy during present hospital stay 4. Pregnancy 5. Known primary or secondary severe immunodeficiency
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Hospital Münster | Münster | Germany | 48149 |
Sponsors and Collaborators
- University Hospital Muenster
Investigators
- Study Chair: Ertmer, MD, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 06-AnIt-21