drugset / Trial / NCT04706507
Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis
Phase 3
Terminated
205 enrolled
Fred Hutchinson Cancer Center
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupTriple-blindTreatment
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 hypothesis is that IV ganciclovir administered early in critical illness will effectively suppress CMV reactivation in CMV seropositive adults with sepsis-associated acute respiratory failure thereby leading to improved clinical outcomes
Timeline
- Start
- 2021-06-29
- Primary completion
- 2024-10-25
- Completion
- 2025-04-08
Outcome
Missed primary endpoint
Stopped: “due to increased mortality and futility analyses”
registry analysis (superiority test); IV Ganciclovir vs Placebo; p = 0.098; t-test, 2 sided NCT04706507 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ganciclovir | Small molecule | 5 mg/kg | Intravenous |