TracheobronchitisNCT05331417
Bronchoscopic Score for Prediction of Herpes Simplex-virus Type 1 (HSV-1) Reactivation
An observational study of Tracheobronchitis and Herpes Simplex Infection, run by University Hospital Muenster at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheobronchitis, Herpes Simplex Infection
- What is being tested?
- Patients with herpes-simplex infection requiring bronchoscopy
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2021to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients
Who may be able to join
- 1. Adult patients (age ≥18 years) 2. Indication for bronchoscopy during intensive care unit stay 3. Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kathrin Sperling, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Münster
Münster, 48149
Ertmer, MD
About this study
Official title: 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
Read the 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
- Being tested
- Patients with herpes-simplex infection requiring bronchoscopy
- Keywords
- Bronchoscopy
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with herpes-simplex infection requiring bronchoscopyDiagnostic test
Also called Observation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at study inclusion
Secondary outcomes (3)
Correlation of the bronchoscopic score value with quantitative tracheobronchial HSV-1-DNA load
Measured: day of study inclusion
Correlation of the bronchoscopic score value with quantitative blood HSV-1-DNA load
Measured: 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)
Measured: day of study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start30 Sep 2021
- Primary completionMar 2023 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheobronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ertmer, MD, Study chair, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331417
- Sponsor's protocol ID
- 06-AnIt-21
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of a Bronchoscopic Score for Prediction of Tracheobronchial Herpes Simplex Virus Type 1 (HSV-1) Reactivation
- ClinicalTrials.gov ID
- NCT05331417
- Acronym / sponsor ID
- 06-AnIt-21
- Conditions
- Tracheobronchitis, Herpes Simplex Infection
- Keywords
- Bronchoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (1 listed)
- 1. Adult patients (age ≥18 years) 2. Indication for bronchoscopy during intensive care unit stay 3. Written informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with herpes-simplex infection requiring bronchoscopyAlso: ObservationDue 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. | Diagnostic test | – |
Primary outcome
Bronchoscopic score for prediction of tracheobronchial HSV-1 reactivation
Time frame: 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
3 secondary outcomes
Correlation of the bronchoscopic score value with quantitative tracheobronchial HSV-1-DNA load
Time frame: day of study inclusion
Correlation of the bronchoscopic score value with quantitative blood HSV-1-DNA load
Time frame: 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)
Time frame: day of study inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Tracheobronchitis
Active, not recruiting
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Ventilator Associated Tracheobronchitis, Tracheobronchitis
Not yet recruitingPhase 3
Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis
Ventilator-Associated Pneumonia, Ventilator-Associated Tracheobronchitis
Enrolling by invitationObservational study
A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children
Ventilator Associated Pneumonia, Tracheobronchitis
Not yet recruiting
Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
Nosocomial Infection, Nosocomial Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathrin Sperling, MD contact
Ertmer, MD study chair
University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheobronchitis and Herpes Simplex Infection, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Ertmer, MD (+49-251-8347255, ertmer@anit.uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchoscopic score for prediction of tracheobronchial HSV-1 reactivation (time frame: at study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.