Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06520605

Cytomegalovirus Reactivation in Non-Immunosuppressed Patients Requiring Prolonged Mechanical Ventilation

Led by Sanjay Gandhi Postgraduate Institute of Medical Sciences · Updated on 2024-07-26

125

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to investigate the reactivation of Cytomegalovirus (CMV), a common latent virus, in critically ill patients who are not immunosuppressed but require prolonged mechanical ventilation. CMV reactivation has been observed in up to half of such patients and is linked to longer ICU stays and higher mortality. The study focuses on understanding how often CMV reactivates and how it relates to illness severity in this specific patient group. The study will include adult ICU patients needing mechanical ventilation for at least seven days who test positive for CMV antibodies. These patients will be monitored weekly for CMV reactivation in blood samples for up to 28 days after ventilation starts. For those with CMV reactivation, viral load will be tracked weekly for an additional three weeks or until ICU discharge. Tracheal aspirate samples will also be collected from patients with artificial airways. Participants will have regular blood and respiratory sample collections during their ICU stay. Researchers will assess CMV reactivation rates and track viral load changes, correlating these with illness severity. The primary outcomes include measuring CMV reactivation prevalence up to four weeks and evaluating viral load in relation to illness severity for three weeks after reactivation. The study will continue until ICU discharge or the completion of monitoring periods, providing detailed data on CMV behavior in this patient population.

CONDITIONS

Brief Title

Cytomegalovirus Reactivation in ICU Patients Requiring Prolong Mechanical Ventilation

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • ICU patients requiring prolonged mechanical ventilation for at least 7 days
  • Confirmed CMV seropositivity (presence of Anti CMV IgG antibodies)
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Use of antiviral medication within the last 7 days
  • Mechanical ventilation for more than 14 days before ICU admission
  • Known or suspected immune deficiency (including organ or stem cell transplant, HIV infection, blood cancers, immunosuppressive medication usage, chemotherapy, or radiotherapy within the past year)
  • Pregnancy
  • Lack of consent to participate in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 4 weeks after the initiation of mechanical ventilation

Participants who are CMV seropositive and meet inclusion criteria are observed for cytomegalovirus reactivation during their ICU stay.

Weekly visits for up to 4 weeks

Long-term Monitoring

Duration - Up to 3 weeks after CMV reactivation or until ICU discharge

Participants with CMV reactivation are followed to monitor viral load kinetics during their ICU stay.

Weekly visits for up to 3 weeks

Trial Site Locations

Total: 1 location

1

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, India, 226014

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Research Team

M

Mohan Gurjar, MD, PDCC

K

Kuldeep S Sindhlian, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Frequently Asked Questions

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