Bronchoscopic Score for Prediction of Herpes Simplex-virus Type 1 (HSV-1) Reactivation

Recruiting

• Conditions: Tracheobronchitis; Herpes Simplex Infection

• Registration Number: NCT05331417
• Lead Sponsor: University Hospital Muenster

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.

Study Timeline

• Study Start: 2021-09-30
• Status Verified: 2022-04
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15
• Primary Completion: 2023-03
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Münster; 🇩🇪 Münster, Germany