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Trial record 89 of 126 for:    HSV-2

Herpes Simplex Reactivation in Adult Critical Care Patients

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ClinicalTrials.gov Identifier: NCT02322476
Recruitment Status : Unknown
Verified December 2014 by Søren Aalbæk Madsen, Rigshospitalet, Denmark.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Søren Aalbæk Madsen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment
Herpes Simplex I Herpes Simplex II Other: No intervention will be performed

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.


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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Herpes Simplex Reactivation in Adult Critical Care Patients
Study Start Date : January 2015
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention will be performed
    No intervention will be performed


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ 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

  2. ICU length of stay [ 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. 30/90 day mortality [ Time Frame: 30/90 days ]

Biospecimen Retention:   Samples With DNA
blood tracheal secretions


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult critically ill patients
Criteria

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

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Responsible Party: Søren Aalbæk Madsen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02322476     History of Changes
Other Study ID Numbers: HSV-ITA-RH
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases