- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00699868
Immune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients (2006/25)
June 1, 2012 updated by: Assistance Publique Hopitaux De Marseille
Cellular Immunity, Cytomegalovirus Infection and Septic Shock in ICU Patients
This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia.
Study Overview
Status
Completed
Conditions
Detailed Description
Candidates will be screened with medical history and blood tests.Then, 2 groups of 20 patients (with or without CMV reactivation) matched for CMV status will be compared for their immune system against CMV.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Marseille, France, 13009
- Hôpital de Sainte Marguerite- Service de Réanimation Médicale
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age more than 18-year-old
- Informed consent
Exclusion Criteria:
- minors,
- pregnant or lactating women,
- adults under guardianship,
- immunosuppression at the entrance to resuscitation,
- AIDS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Infection to CMV
|
Sampling of blood
|
OTHER: 2
Group "control CMV"
|
Sampling of blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bring to light the quantitative and qualitative immunological modifications of the present cells NK before the arisen of an infection to CMV
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bring to light the quantitative and qualitative immunological modifications of cells NK in the consequences of an infectious shock
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean-Marie FOREL, MD, Assistance Publique des Hôpitaux de Marseille
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Matta J, Baratin M, Chiche L, Forel JM, Cognet C, Thomas G, Farnarier C, Piperoglou C, Papazian L, Chaussabel D, Ugolini S, Vely F, Vivier E. Induction of B7-H6, a ligand for the natural killer cell-activating receptor NKp30, in inflammatory conditions. Blood. 2013 Jul 18;122(3):394-404. doi: 10.1182/blood-2013-01-481705. Epub 2013 May 17.
- Forel JM, Chiche L, Thomas G, Mancini J, Farnarier C, Cognet C, Guervilly C, Daumas A, Vely F, Xeridat F, Vivier E, Papazian L. Phenotype and functions of natural killer cells in critically-ill septic patients. PLoS One. 2012;7(12):e50446. doi: 10.1371/journal.pone.0050446. Epub 2012 Dec 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ACTUAL)
January 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
June 13, 2008
First Submitted That Met QC Criteria
June 17, 2008
First Posted (ESTIMATE)
June 18, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 4, 2012
Last Update Submitted That Met QC Criteria
June 1, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-A01197-46
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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