NCT02322476

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1 month

First QC Date

November 19, 2014

Last Update Submit

December 22, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Duration of mechanical ventilation

    Approximately 16 days

  • ICU length of stay

    Approximately 16 days

  • 30/90 day mortality

    30/90 days

Interventions

No intervention will be performed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult critically ill patients

You may qualify if:

  • Admission to ICU
  • Expected length of stay (LOS) \>72 hours
  • Informed consent by patient, relative or guardian

You may not qualify if:

  • Ongoing antiviral treatment/prophylaxis
  • Expected LOS \<72 hours
  • Withdrawal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

blood tracheal secretions

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 23, 2014

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

December 23, 2014

Record last verified: 2014-12