Clinical trial NCT05331417: Bronchoscopic Score for Prediction of Herpes Simplex-virus Type 1 (HSV-1) Reactivation
Official title: Performance of a Bronchoscopic Score for Prediction of Tracheobronchial Herpes Simplex Virus Type 1 (HSV-1) Reactivation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheobronchitis
Herpes Simplex Infection
Keywords: Bronchoscopy
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bronchoscopic score for prediction of tracheobronchial HSV-1 reactivation
timeFrame: at study inclusion
Secondary outcomes:
measure: Correlation of the bronchoscopic score value with quantitative tracheobronchial HSV-1-DNA load
timeFrame: day of study inclusion
measure: Correlation of the bronchoscopic score value with quantitative blood HSV-1-DNA load
timeFrame: day of study inclusion
measure: 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)
timeFrame: day of study inclusion
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
name: Ertmer, MD
role: STUDY_CHAIR
References: