Herpes Simplex INCT02322476
Herpes Simplex Reactivation in Adult Critical Care Patients
An observational study of Herpes Simplex I and Herpes Simplex II, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care unit (ICU). Several studies have documented a high frequency of HSV reactivation in critically ill patients despite that clinical impact remains unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Simplex I, Herpes Simplex II
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2015
- 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: Adult critically ill patients
Who may be able to join
- Admission to ICU
- Expected length of stay (LOS) >72 hours
- Intubated <24 hours prior to inclusion
- Informed consent by patient, relative or guardian
Who cannot join
- Ongoing antiviral treatment/prophylaxis
- Expected LOS <72 hours
- Intubation >24 hours prior to inclusion
- Withdrawal of informed consent
About this study
Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care unit (ICU). Several studies have documented a high frequency of HSV reactivation in critically ill patients despite that clinical impact remains unknown.
Read the detailed description
Normally primary HSV infection is asymptomatic but can under certain circumstances cause manifestations such as encephalitis and bronchopneumonitis. Bruynseels showed that HSV was detectable in the throat of two percent of healthy volunteers and three percent of patients not admitted to the ICU, this provides a broad "recruitment-base" for either latent or lytic HSV infection in the ICU. Viral dissemination to the bloodstream is seen in neonates , immunocompromised patients, but also in patients with primary herpetic gingivostomatitis. Patients testing polymerase chain reaction (PCR) positive for herpes simplex DNA in blood, have a higher rate of systemic symptoms than those testing PCR negative for herpes simplex. Additionally it is known that HSV suppression in HIV patients has beneficial effects. PCR, now being available for more than a decade, has been shown to provide a more sensitive method for the detection of HSV than culture, but viral detection does not per se translate to viral disease thus the impact of disseminated HSV infection in ICU patients remains unclear.
The investigators would like to investigate the incidence of HSV reactivation in blood and tracheal secretions critically ill patients and its impact on clinical course.
- Conditions
- Herpes Simplex I, Herpes Simplex II
- Being tested
- No intervention will be performed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be performedOther
No intervention will be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HSV reactivation
Participants will be followed for the duration of the hospital stay with sampling of blood or tracheal secretions every 4 days until end of the viral reactivation period
Measured: Approximately 16 days
Secondary outcomes (3)
Duration of mechanical ventilation
Participants will be followed for the duration of the hospital stay with sampling of blood or tracheal secretions every 4 days until end of the viral reactivation period
Measured: Approximately 16 days
ICU length of stay
Participants will be followed for the duration of the hospital stay with sampling of blood or tracheal secretions every 4 days until end of the viral reactivation period
Measured: Approximately 16 days
30/90 day mortality
Measured: 30/90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex IStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Søren Aalbæk Madsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322476
- Sponsor's protocol ID
- HSV-ITA-RH
- Status last verified
- Dec 2014
- First submitted
- 19 Nov 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herpes Simplex Reactivation in Adult Critical Care Patients
- ClinicalTrials.gov ID
- NCT02322476
- Acronym / sponsor ID
- HSV-ITA-RH
- Conditions
- Herpes Simplex I, Herpes Simplex II
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- 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.
Welcome or not Herpes Simplex virus (HSV) is an ever present guest in the intensive care unit (ICU). Several studies have documented a high frequency of HSV reactivation in critically ill patients despite that clinical impact remains unknown.
Detailed description
Normally primary HSV infection is asymptomatic but can under certain circumstances cause manifestations such as encephalitis and bronchopneumonitis. Bruynseels showed that HSV was detectable in the throat of two percent of healthy volunteers and three percent of patients not admitted to the ICU, this provides a broad "recruitment-base" for either latent or lytic HSV infection in the ICU. Viral dissemination to the bloodstream is seen in neonates , immunocompromised patients, but also in patients with primary herpetic gingivostomatitis. Patients testing polymerase chain reaction (PCR) positive for herpes simplex DNA in blood, have a higher rate of systemic symptoms than those testing PCR negative for herpes simplex. Additionally it is known that HSV suppression in HIV patients has beneficial effects. PCR, now being available for more than a decade, has been shown to provide a more sensitive method for the detection of HSV than culture, but viral detection does not per se translate to viral disease thus the impact of disseminated HSV infection in ICU patients remains unclear.
The investigators would like to investigate the incidence of HSV reactivation in blood and tracheal secretions critically ill patients and its impact on clinical course.
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
- Adult critically ill patients
Key inclusion criteria (4 listed)
- Admission to ICU
- Expected length of stay (LOS) >72 hours
- Intubated <24 hours prior to inclusion
- Informed consent by patient, relative or guardian
Key exclusion criteria (4 listed)
- Ongoing antiviral treatment/prophylaxis
- Expected LOS <72 hours
- Intubation >24 hours prior to inclusion
- Withdrawal of informed consent
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 |
|---|---|---|
| No intervention will be performedNo intervention will be performed | Other | – |
Primary outcome
Incidence of HSV reactivation
Time frame: Approximately 16 days
Participants will be followed for the duration of the hospital stay with sampling of blood or tracheal secretions every 4 days until end of the viral reactivation period
3 secondary outcomes
Duration of mechanical ventilation
Time frame: Approximately 16 days
ICU length of stay
Time frame: Approximately 16 days
30/90 day mortality
Time frame: 30/90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Simplex I and Herpes Simplex II, run by Copenhagen University Hospital, Rigshospitalet.
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 4 inclusion and 4 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HSV reactivation (time frame: Approximately 16 days). 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 23 Dec 2014.