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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02843880
Other study ID # 2012/130
Secondary ID
Status Terminated
Phase N/A
First received March 23, 2016
Last updated July 22, 2016
Start date March 2013
Est. completion date May 2016

Study information

Verified date July 2016
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Universitary Hospital - Medical Intensive Care Station Grenoble

Sponsors (1)

Lead Sponsor Collaborator
AdministrateurDRC

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary Mortality Day 28 No
Secondary Length of ICU stay About 90 days No
Secondary Duration of mechanical ventilation About 90 days No
Secondary Occurence of nosocomial infections About 90 days No
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