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

Sponsor
University Hospital Muenster (Other)
Overall Status
Recruiting
CT.gov ID
NCT05331417
Collaborator
(none)
100
1
46
2.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Performance of a Bronchoscopic Score for Prediction of Tracheobronchial Herpes Simplex Virus Type 1 (HSV-1) Reactivation
Actual Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Aug 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Correlation of the bronchoscopic score value with quantitative tracheobronchial HSV-1-DNA load [day of study inclusion]

  2. Correlation of the bronchoscopic score value with quantitative blood HSV-1-DNA load [day of study inclusion]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Münster Münster Germany 48149

Sponsors and Collaborators

  • University Hospital Muenster

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT05331417
Other Study ID Numbers:
  • 06-AnIt-21
First Posted:
Apr 15, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital Muenster
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022