Cytomegalovirus Infection in Critically Ill Patients and Patients Receiving Anticancer Therapy

NCT04280380 | Unknown

• 2 other identifiers: 19.09.1441-GHMHM-CMV19
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

CMV

Keywords

CMV; intensive care; prevalence

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Mechanical ventilated patients without cancer

This observational, cohort, retrospective and multicenter study will be performed during a period of 16 months at the 5 medical/surgical ICUs from HM Hospitals group. The recruitment will be performed by volume of patients: recruitment of the first 300 patients without cancer will start the 15th of January 2018 and will end once the last patient has been included; likewise, recruitment of the first patient with cancer will start on the same date and will end once the last patient (of 100) is recruited. Patients undergoing any type of anticancer therapy within the previous 3 month of ICU admission will be analyzed as part of the overall group but also as an independent subgroup of patients. Inclusion criteria: (a) age \>=18 y.o., (b) admission to the intensive care unit with an expectancy to stay longer than 72 hours and requiring invasive mechanical ventilation.

Diagnostic Test: Real time PCR

Mechanical ventilated patients with cancer

This observational, cohort, retrospective and multicenter study will be performed during a period of 16 months at the 5 medical/surgical ICUs from HM Hospitals group. The recruitment will be performed by volume of patients: recruitment of the first 300 patients without cancer will start the 15th of January 2018 and will end once the last patient has been included; likewise, recruitment of the first patient with cancer will start on the same date and will end once the last patient (of 100) is recruited. Patients undergoing any type of anticancer therapy within the previous 3 month of ICU admission will be analyzed as part of the overall group but also as an independent subgroup of patients. Inclusion criteria: (a) age \>=18 y.o., (b) admission to the intensive care unit with an expectancy to stay longer than 72 hours and requiring invasive mechanical ventilation.

Diagnostic Test: Real time PCR

Interventions

Real time PCR DIAGNOSTIC_TEST

At inclusion, serum samples will be collected to determine CMV serological status. Plasma samples will be collected weekly for CMV PCR analysis. Antibodies for CMV will be assessed using a commercial enzyme immunoassay kit for detection of total antibodies to CMV (LIAISON CMV IgG assay, DiaSorin S.p.A). DNA will be extracted in 200 μL of plasma eluted in 60 μL of elution buffer using a NucliSENS easyMAG system (bioMérieux, Boxtel, The Netherlands). Samples will be amplified using Affigene CMV Trender diagnostic assay (Cepheid AB, Bromma, Sweden), according to the manufacturer instructions. Amplification will be performed on a MX3000P instrument (Stratagene Instruments Systems, La Jolla, CA, USA). Samples with \>500 copies/mL of plasma will be considered positive.

Mechanical ventilated patients with cancer; Mechanical ventilated patients without cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with \>=18 years old, after admission to the intensive care unit with an expectancy to stay longer than 72 hours and requiring invasive mechanical ventilation, whom are not included at exclusion criteria.

You may qualify if:

• age \>=18 y.o.,
• admission to the intensive care unit with an expectancy to stay longer than 72 hours and requiring invasive mechanical ventilation.

You may not qualify if:

• survival expectation previous to ICU admission less than 6 months,
• intubation after 12 hours of ICU admission
• limitation of the therapeutic effort previous or during the ICU stay,
• admission to the ICU during the previous 3 months
• not agreeing to sign an informed consent.

Sponsors & Collaborators

• Fundación de investigación HM: lead
• Merck Sharp & Dohme LLC: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

All eligible patients will be screened for CMV reactivation or primary infection until day 28 of ICU admission, discharge or death. For all eligible patients, a blood sample will be drawn for CMV serology and PCR testing at ICU admission (day 0) and then once a week for PCR testing (every Monday for logistic reasons) until day 28th of ICU admission, ICU discharge or death.

Central Study Contacts

Fernando Gómez, Msc

CONTACT

917089900; fghermoso@hmhospitales.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 21, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share