Status:
TERMINATED
Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This is a phase 3 study designed to evaluate whether the administration of ganciclovir increases ventilator-free days in immunocompetent patients with sepsis associated acute respiratory failure. Our ...
Eligibility Criteria
Inclusion
- Subject/next of kin informed consent
- Age \> 18 years
- CMV IgG seropositive by lateral flow assay (LFA) or standard serologic methods
- Receiving care in an ICU
- Acute respiratory failure as defined in Section 4.1.1.
- Expected to require respiratory support for at least 2 more days after randomization
- Infection confirmed or suspected by the treating clinician and felt to be the source of acute respiratory failure (Respiratory failure associated with infection confers at least 2 SOFA points above assumed baseline SOFA score of 0, thereby meeting Sepsis-3 definition).
Exclusion
- Known or suspected immunosuppression, including:
- HIV+ (i.e. prior positive test or clinical signs of suspicion of HIV/AIDS; a negative HIV test is not required for enrollment)
- stem cell transplantation:
- within 6 months after autologous transplantation or
- within 1 years after allogeneic transplantation (regardless of immunosuppression)
- greater than 1 year of allogeneic transplantation if still taking systemic immunosuppression or prophylactic antibiotics (e.g. for chronic graft versus host disease) Note: if details of stem cell transplantation are unknown, patients who do not take systemic immunosuppression and do not take anti-infective prophylaxis are acceptable for enrollment and randomization.
- solid organ transplantation with receipt of systemic immunosuppression (any time)
- cytotoxic anti-cancer chemotherapy within the past three months (Note: next-of-kin estimate is acceptable)
- congenital immunodeficiency requiring antimicrobial prophylaxis (e.g. TMP-SMX, dapsone, antifungal drugs, intravenous immunoglobulin)
- receipt of one or more of the following in the indicated time period (see Appendix C):
- within 6 months: alemtuzumab, antithymocyte/antilymphocyte antibodies, or other immunosuppressive drugs associated with CMV reactivation Note: if no information on these agents is available in the history and no direct or indirect evidence exists from the history that any condition exists that requires treatment with these agents (based on the investigator's assessment), the subject may be enrolled. For all drug information, next-of-kin estimates are acceptable. See Appendix C for commonly prescribed immunosuppressive agents. Information on the use of biologics with moderate immunosuppressive effect but no known effect on CMV are permitted and will be recorded in the CRFs.
- Expected to survive \< 72 hours (in the opinion of the investigator)
- Has been hospitalized for \> 120 hours (subjects who are transferred from a chronic care ward, such as a rehabilitation unit, with an acute event are acceptable).
- Pregnant or breastfeeding (either currently or expected within one month). Note: for women of childbearing age (18-60 years, unless documentation of surgical sterilization \[hysterectomy, tubal ligation, oophorectomy\]), if a pregnancy test has not been done as part of initial ICU admission work-up, it will be ordered stat and documented to be negative before randomization. Both urine and blood tests are acceptable.
- Absolute neutrophil count \< 1,000/mm3 (if no ANC value is available, the WBC must be \> 2500/mm3)
- Use of anti-CMV drugs (cidofovir, letermovir, foscarnet, valganciclovir, ganciclovir) within seven (7) days of patient randomization.
- Currently enrolled in an interventional trial of an investigational therapeutic agent known or suspected to have anti-CMV activity or to be associated with significant known hematologic toxicity (prior approval required).
- At baseline patients who have both a tracheostomy, and have been on continuous 24-hour chronic mechanical ventilation.
- Patients with Child Class C Cirrhosis.
- Patients with severe (requiring home oxygen) pre-existing interstitial lung disease.
- Allergy to ganciclovir
- Incarcerated
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2025
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04706507
Start Date
June 29 2021
End Date
April 8 2025
Last Update
December 12 2025
Active Locations (20)
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1
University of Colorado Denver
Denver, Colorado, United States, 80204
2
Johns Hopkins University
Baltimore, Maryland, United States, 21218
3
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
4
University of Michigan
Ann Arbor, Michigan, United States, 48109-5360