Reactivation of CMV Infection in Immunocompetent Patients Under Severe Stress (RECYSTRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397058
Recruitment Status : Unknown
Verified July 2011 by University of Athens.
Recruitment status was:  Recruiting
First Posted : July 19, 2011
Last Update Posted : August 15, 2011
Information provided by:
University of Athens

Brief Summary:

Background. Human herpes viruses establish lifelong latency after primary infection and may reactivate in immunosuppressed patients causing significant morbidity and mortality. In immunocompetent patients, although reactivation may occur disease development is deterred by the competent host immune response. Recent studies indicate that approximately one third of CMV seropositive immunocompetent ICU patients present with CMV reactivation associated with poor outcome, potentially secondary to the stress incurred. CMV reactivation among immunocompetent critically ill children has not been assessed.

Study Hypothesis: Identifiable risk factors associated with CMV reactivation exist and may be used for future assessment of antiviral prophylaxis administration.

Aim: Primary aim is to identify risk factors associated with CMV reactivation and poor outcome in immunocompetent children and adults under severe stress. Whether CMV reactivation occurs in critically ill children and its clinical implications remains to be determined. Secondary aim is to study the role of cellular signaling pathways of inflammation and specific adaptive immunity during this process.

Work packages: A multicenter observational prospective study will be conducted among CMV seropositive pediatric and adult ICU patients. Patient clinical progress, laboratory findings, management, and complications will be recorded during the 28 days following ICU admission. Salivary free cortisol levels, plasma catecholamines, and serum cytokines levels will be measured to assess stress. CMV reactivation will be evaluated weekly by detecting CMV-DNA in peripheral blood and bronchial wash samples with real-time PCR. In a patient subsample, the nuclear factor κB and intracellular GC receptor will be measured in peripheral blood monocytes to study cellular signaling pathways of inflammation. The adaptive immune response to CMV infection following in vitro viral polypeptide stimulation will be prospectively examined in a subset of patients.

Expected Results: The study will provide original data on critically ill children. Further knowledge regarding risk factors associated with CMV reactivation and poor outcome will be accumulated. Novel information regarding the role of cellular inflammation and specific adaptive immune responses during CMV reactivation will be gathered.

Condition or disease
Cytomegalovirus Viraemia Stress, Physiological Receptor, Hormonal; Disorder Other Deficiency of Cell-mediated Immunity

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of CMV Reactivation in Immunocompetent Children and Adult ICU Patients
Study Start Date : June 2011
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Risk factors associated with CMV reactivation in critically ill children and adults [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Role of cellular signaling and adaptive immunity [ Time Frame: 7 days ]

Biospecimen Retention:   Samples With DNA
As described above, whole blood will be collected on a weekly basis and DNA will be extracted to detect CMV-DNA. The remaining DNA will be retained

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ICU patients

Inclusion Criteria:

  • previously healthy children 5-16 years old (group A) and adults (group B)
  • no known immunosuppression (secondary to underlying disease or medications),
  • residence near the ICU (ability to return for follow up on day 28 post admission)
  • availability of patient guardian or first degree relative willing to provide written informed consent

Exclusion Criteria:

  • imminent death
  • expected ICU stay <48 hours
  • intubation prior to admission (in a different center) for >48 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397058

Contact: Vassiliki Papaevangelou +30-2107793000
Contact: Ioanna Dimopoulou +30-2105832177

University of Athens Recruiting
Athens, Greece
Contact: Vassiliki Papaevangelou   
Principal Investigator: Ioanna Dimopoulou         
Principal Investigator: Vassiliki Papaevangelou         
Principal Investigator: Chrisitina Routsi         
Sponsors and Collaborators
University of Athens
Principal Investigator: Vassiliki Papaevangelou Univeristy of Athens , Greece

Responsible Party: Vassiliki Papaevangelou?Associate Professor of Pediatrics, University of Athens Identifier: NCT01397058     History of Changes
Other Study ID Numbers: UAthens
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Virus Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes