NCT02003196

Brief Summary

Morbidity and mortality of ICU patients is increased by the development of a "immunosuppression" systemic (IS). This IS develops in the early hours of hospitalization and is responsible for severe infections, including viral reactivations (Cytomegalovirus or Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and mortality in intensive care units. In clinical practice, they are searched at the onset of organ failure or unexplained fever. The investigators wish to conduct this research in the stroke patients to assess the predictive power of these viral reactivations on the duration of mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

6.2 years

First QC Date

December 2, 2013

Last Update Submit

August 24, 2021

Conditions

Keywords

Brain injuryvirusimmunosuppressionmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Ventilatory-free days at day 90

    90 days

Secondary Outcomes (4)

  • Bacterial hospital acquiered infection

    28 days

  • organ failure

    28 days

  • hospitalisation length of stay

    28 days

  • Mortality

    28 days and 90 days

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow Coma Scale \<= 12 * Age between 18 and 75 years

You may qualify if:

  • Hospitalisation in intensive care unit
  • Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow Coma Scale \<= 12
  • Age between 18 and 75 years
  • Mechanical ventilation \> 24 hours

You may not qualify if:

  • encephalopathy post anoxy
  • active cancer
  • Immunosuppresseur treatment
  • pregnancy
  • history of autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, France

Location

Related Publications (2)

  • Anani H, Destras G, Regue H, Bulteau S, Bressollette-Bodin C, Roquilly A, Josset L. Metagenome-assembled complete genome of Bohxovirus, a virulent bacteriophage involved in the prediction of hospital-acquired pneumonia in intubated critically ill patients. Microbiol Resour Announc. 2025 Dec 11;14(12):e0059225. doi: 10.1128/mra.00592-25. Epub 2025 Oct 29.

  • Anani H, Destras G, Bulteau S, Castain L, Semanas Q, Burfin G, Petrier M, Martin FP, Poulain C, Dickson RP, Bressollette-Bodin C, Roquilly A, Josset L. Lung virome convergence precedes hospital-acquired pneumonia in intubated critically ill patients. Cell Rep Med. 2025 Sep 16;6(9):102289. doi: 10.1016/j.xcrm.2025.102289. Epub 2025 Sep 5.

MeSH Terms

Conditions

Brain InjuriesVirus Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesInfections

Study Officials

  • Karim Asehnoune, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 6, 2013

Study Start

January 5, 2014

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations