Herpes Simplex Reactivation in Adult Critical Care Patients

NCT ID: NCT02322476

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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

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Herpes Simplex I Herpes Simplex II

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention will be performed

No intervention will be performed

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Søren Aalbæk Madsen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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HSV-ITA-RH

Identifier Type: -

Identifier Source: org_study_id