CMV Clinical Trial
— CMV-ICUOfficial title:
Incidence, Natural History and Outcome of Cytomegalovirus Infection in Critically Ill Patients and Patients Receiving Anticancer Therapy
Cytomegalovirus (CMV) is the most common member of the herpes viruses to infect humans. Its double-stranded linear DNA duplex contains 165 genes that encode viral proteins that mimic and interact with human cellular proteins and are related to its virulence and latency. CMV primary infection is usually acquired in the adolescence and follows a benign course; however it might reactivate in patients with immune suppression leading to a high mortality and morbidity in this group of patients. There is growing evidence that critically ill immunocompetent patients can develop CMV disease [Limaye et al. JAMA. 2008;300(4):413; Ziemann et al. Crit Care Med. 2008;36(12):3145]. However, results of the incidence of CMV disease in critically ill patients is unpredictable due to the wide range of these results, from a 0% to 98% [Al-Omari et al. Ann. Intensive Care (2016) 6:110]. This inconsistency could be explained by many factors such as (i) variation in the definition of CMV disease (old studies consider seropositivity as evidence of disease, while others use newer technologies like PCR and/or antigen detection), (ii) variation in inclusion criteria (some studies include only seropositive patients therefore assessing reactivation rate of CMV, others also include seronegative patients thus evaluating also new infections) or (iii) variation in studied populations (e.g. septic, surgical, burn or postcardiac surgery patients or patients under mechanical ventilation).
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. age >=18 y.o., 2. admission to the intensive care unit with an expectancy to stay longer than 72 hours and requiring invasive mechanical ventilation. Exclusion Criteria: 1. survival expectation previous to ICU admission less than 6 months, 2. intubation after 12 hours of ICU admission 3. limitation of the therapeutic effort previous or during the ICU stay, 4. admission to the ICU during the previous 3 months 5. not agreeing to sign an informed consent. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fundación de investigación HM | Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cytomegalovirus Prevalence | Cytomegalovirus prevalence after admission to the intensive care unit with an expectancy to stay longer than 72 hours | From study start date (March, 2020) until ending enrollment period (16 months later) |
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