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

NCT05331417 | Unknown

• 1 other identifier: 06-AnIt-21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Tracheobronchitis; Herpes Simplex Infection

Keywords

Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Interventions

Patients with herpes-simplex infection requiring bronchoscopy DIAGNOSTIC_TEST

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.

Also known as: Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients

You may qualify if:

• \. Adult patients (age ≥18 years) 2. Indication for bronchoscopy during intensive care unit stay 3. Written informed consent

You may not qualify if:

• \. 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Münster

Münster, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ertmer, MD

  University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine

  STUDY CHAIR

Central Study Contacts

Christian Ertmer, MD

CONTACT

+49-251-8347255; ertmer@anit.uni-muenster.de

Kathrin Sperling, MD

CONTACT

sperlink@uni-muenster.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 15, 2022
• Study Start: September 30, 2021
• Primary Completion: March 1, 2023
• Study Completion: August 1, 2025
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)