NCT05331417

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

Performance of a Bronchoscopic Score for Prediction of Tracheobronchial Herpes Simplex Virus Type 1 (HSV-1) Reactivation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tracheobronchitis
• Herpes Simplex Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Patients 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.

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-03-01
• Completion: 2025-08-01
• First posted: 2022-04-15
• Last updated: 2022-04-15

Locations

1 site across 1 country: Germany