Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Immune Response and Cytomegalovirus in Intensive Care Unit (ICU) Patients (2006/25)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00699868
First received: June 13, 2008
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Cytomegalovirus Infection
Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Cellular Immunity, Cytomegalovirus Infection and Septic Shock in ICU Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bring to light the quantitative and qualitative immunological modifications of cells NK in the consequences of an infectious shock [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: March 2008
Study Completion Date: August 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Infection to CMV
Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings
Sampling of blood
2
Group "control CMV"
Other: Sampling of blood, phenotypic analysis sub-populations NK by cytometric of stream in multiple markings
Sampling of blood

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699868

Locations
France
Hôpital de Sainte Marguerite- Service de Réanimation Médicale
Marseille, France, 13009
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Jean-Marie FOREL, MD Assistance Publique des Hôpitaux de Marseille
  More Information

No publications provided by Assistance Publique Hopitaux De Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00699868     History of Changes
Other Study ID Numbers: 2007-A01197-46
Study First Received: June 13, 2008
Last Updated: June 1, 2012
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Communicable Diseases
Cytomegalovirus Infections
Infection
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014