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

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

Study Overview

• Status: Recruiting
• Conditions: Tracheobronchitis; Herpes Simplex Infection
• Intervention / Treatment: Diagnostic test: Patients with herpes-simplex infection requiring bronchoscopy

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Christian Ertmer, MD; Phone Number: +49-251-8347255; Email: ertmer@anit.uni-muenster.de
• Study Contact Backup: Name: Kathrin Sperling, MD; Email: sperlink@uni-muenster.de

Study Locations

• Germany
  • Münster, Germany, 48149
    • Recruiting
    • University Hospital Münster
    • Contact: Ertmer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Study Chair: Ertmer, MD, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Bronchoscopy
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex
• Other Study ID Numbers: 06-AnIt-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No