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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by University of Athens
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT01397058
First received: July 18, 2011
Last updated: August 12, 2011
Last verified: July 2011
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of CMV Reactivation in Immunocompetent Children and Adult ICU Patients

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Risk factors associated with CMV reactivation in critically ill children and adults [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Role of cellular signaling and adaptive immunity [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 275
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

ICU patients

Criteria

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
  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: NCT01397058

Contacts
Contact: Vassiliki Papaevangelou +30-2107793000 vpapaev@med.uoa.gr
Contact: Ioanna Dimopoulou +30-2105832177 idimo@otenet.gr

Locations
Greece
University of Athens Recruiting
Athens, Greece
Contact: Vassiliki Papaevangelou       vpapaev@med.uoa.gr   
Principal Investigator: Ioanna Dimopoulou         
Principal Investigator: Vassiliki Papaevangelou         
Principal Investigator: Chrisitina Routsi         
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Vassiliki Papaevangelou Univeristy of Athens , Greece
  More Information

Publications:
Responsible Party: Vassiliki Papaevangelou?Associate Professor of Pediatrics, University of Athens
ClinicalTrials.gov Identifier: NCT01397058     History of Changes
Other Study ID Numbers: UAthens
Study First Received: July 18, 2011
Last Updated: August 12, 2011
Health Authority: Greece: National Organization of Medicines

ClinicalTrials.gov processed this record on September 16, 2014