Herpes Simplex Infection, Tracheobronchitis
Conditions
Keywords
Bronchoscopy
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
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.
Interventions
DIAGNOSTIC_TESTPatients with herpes-simplex infection requiring bronchoscopy
Due to the observational design of the study, no study-specific interventions are performed. The indication for bronchoscopy is determined by the responsible ICU physicians. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians.
Sponsors
University Hospital Muenster
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Adult patients (age ≥18 years) 2. Indication for bronchoscopy during intensive care unit stay 3. Written informed consent
Exclusion criteria
* 1\. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactChristian Ertmer, MD
Backup ContactKathrin Sperling, MD
Outcome results
None listed