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Herpes Simplex Reactivation in Adult Critical Care Patients

Herpes Simplex Reactivation in Adult Critical Care Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02322476
Enrollment
140
Registered
2014-12-23
Start date
2015-01-31
Completion date
2015-08-31
Last updated
2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex I, Herpes Simplex II

Brief 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.

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.

Interventions

No intervention will be performed

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admission to ICU * Expected length of stay (LOS) \>72 hours * Intubated \<24 hours prior to inclusion * Informed consent by patient, relative or guardian

Exclusion criteria

* Ongoing antiviral treatment/prophylaxis * Expected LOS \<72 hours * Intubation \>24 hours prior to inclusion * Withdrawal of informed consent

Design outcomes

Primary

MeasureTime frameDescription
Incidence of HSV reactivationApproximately 16 daysParticipants 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

Secondary

MeasureTime frameDescription
Duration of mechanical ventilationApproximately 16 daysParticipants 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
ICU length of stayApproximately 16 daysParticipants 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
30/90 day mortality30/90 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026