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

CMV Infection Clinical Trial

— CMV-Réa  

Official title:

Predictive Factors of Cytomegalovirus Reactivation or Cytomegalovirus Disease by Immunological Study of Immunocompetent Patients Hospitalized for Septic Shock

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02843880
• Other study ID #: 2012/130
• 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

• CMV Infection
• Cytomegalovirus Infections

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