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

Tracheobronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05331417
• Other study ID #: 06-AnIt-21
• Status: Recruiting
• Start date: September 30, 2021
• Est. completion date: August 2025

Study information

• Verified date: April 2022
• Source: University Hospital Muenster
• Contact: Christian Ertmer, MD
• Phone: +49-251-8347255
• Email: ertmer[@]anit.uni-muenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Simplex Infection
• Tracheobronchitis

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchoscopic score for prediction of tracheobronchial HSV-1 reactivation	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	at study inclusion
Secondary	Correlation of the bronchoscopic score value with quantitative tracheobronchial HSV-1-DNA load		day of study inclusion
Secondary	Correlation of the bronchoscopic score value with quantitative blood HSV-1-DNA load		day of study inclusion
Secondary	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