Herpes Simplex Reactivation in Adult Critical Care Patients

Herpes Simplex II Clinical Trial

Official title:

Herpes Simplex Reactivation in Adult Critical Care Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02322476
• Other study ID #: HSV-ITA-RH
• Status: Not yet recruiting
• Phase: N/A
• First received: November 19, 2014
• Last updated: December 22, 2014
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: December 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Simplex I
• Herpes Simplex II

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 16 days	No
Secondary	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	Approximately 16 days	No
Secondary	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	Approximately 16 days	No
Secondary	30/90 day mortality		30/90 days	No