Reactivation of CMV Infection in Immunocompetent Patients Under Severe Stress (RECYSTRESS)
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|ClinicalTrials.gov 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
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|
|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|
- Risk factors associated with CMV reactivation in critically ill children and adults [ Time Frame: 28 days ]
- Role of cellular signaling and adaptive immunity [ Time Frame: 7 days ]
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT01397058
|Contact: Vassiliki Papaevangelouemail@example.com|
|Contact: Ioanna Dimopouloufirstname.lastname@example.org|
|University of Athens||Recruiting|
|Contact: Vassiliki Papaevangelou email@example.com|
|Principal Investigator: Ioanna Dimopoulou|
|Principal Investigator: Vassiliki Papaevangelou|
|Principal Investigator: Chrisitina Routsi|
|Principal Investigator:||Vassiliki Papaevangelou||Univeristy of Athens , Greece|