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Prediction of Cytomegalovirus (CMV) Reactivation in Intensive Care Unit (ICU) by Immunological Study
CMV-Réa
Predictive Factors of Cytomegalovirus Reactivation or Cytomegalovirus Disease by Immunological Study of Immunocompetent Patients Hospitalized for Septic Shock
1 other identifier
observational
1
1 country
1
Brief Summary
Cytomegalovirus is a herpesviridae whose prevalence in general population is between 50 to 80%. In immunocompetent individuals, CMV remains latent in a number of cells, without any pathological consequence. Immunosuppression may reactivate the virus causing either a CMV-active infection or a CMV disease with attributable symptoms. In Intensive Care Unit (ICU), 6 to 30 % of critically ill patients without classical immunosuppression, as those suffering from septic shock, present CMV reactivation. Our aim is to study the risk factors for developing viremia or CMV disease in ICU patients in septic shock without previous immunodepression and determine the relationship between viral reactivation and this acquired immunity alteration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedJuly 26, 2016
July 1, 2016
3.2 years
March 23, 2016
July 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of CMV disease
CMV disease is defined by occurence of viremia and/or an organ failure
From Day 3 of ICU admission to the end of their stay in ICU (in average, from 6 days to 4 weeks)
Secondary Outcomes (4)
Mortality
Day 28
Length of ICU stay
About 90 days
Duration of mechanical ventilation
About 90 days
Occurence of nosocomial infections
About 90 days
Study Arms (1)
Septic shock patients
Septic shock patients staying over 3 days mechanically ventilated in the ICU
Eligibility Criteria
Patients admitted in ICU for septic shock, without previous immunodepression, and who will stay in ICU for over 3 days, mechanically ventialted
You may qualify if:
- years or older
- ICU admission for more than 3 days
- Admission for septic shock
- Patient with mechanical invasive ventilation
You may not qualify if:
- Immunodepression status before ICU admission (chemotherapy, bone marrow or solid organ transplantation, long time corticosteroid treatment, immunosuppressant therapy, HIV infection)
- Seronegative patient for CMV
- Patient under anti-virus treatment
- Patient under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitary Hospital - Medical Intensive Care Station
Grenoble, 38043, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr Maxime Lugosi
Study Record Dates
First Submitted
March 23, 2016
First Posted
July 26, 2016
Study Start
March 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 26, 2016
Record last verified: 2016-07