Prediction of Cytomegalovirus (CMV) Reactivation in Intensive Care Unit (ICU) by Immunological Study

NCT ID: NCT02843880

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Immunosuppression statuses causing both CMV active infection or disease are mainly consecutive to HIV infection, bone marrow or solid organ transplantation. However, in severely ill patients, as in septic shock, it has been proved that after a hyper-inflammatory phase occurred a negative control of the immunity, resulting in a paralysed or impaired immune system. The length and extent of this immunodeficiency is correlated with the duration of ICU stay, the occurrence of nosocomial infection and mortality.

A better understanding of CMV's natural history reactivation in the critically ill patient would better define the benefits from a specific therapy.

Conditions

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CMV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic shock patients

Septic shock patients staying over 3 days mechanically ventilated in the ICU

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* ICU admission for more than 3 days
* Admission for septic shock
* Patient with mechanical invasive ventilation

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AdministrateurDRC

OTHER

Sponsor Role lead

Responsible Party

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AdministrateurDRC

Dr Maxime Lugosi

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitary Hospital - Medical Intensive Care Station

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2012/130

Identifier Type: -

Identifier Source: org_study_id

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