Trial · NCT04706507

Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis

NCT04706507, Phase 3, Terminated, Fred Hutchinson Cancer Center; results first posted 2025-12-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis. Trials, record NCT04706507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04706507

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis
NCT number: NCT04706507
Status: Terminated
Phases: Phase 3
Enrollment: 205 participants, actual
Lead sponsor: Fred Hutchinson Cancer Center
Conditions: Acute Respiratory Failure
Interventions: IV Ganciclovir, Normal saline
First posted: 2021-01-12
Last updated: 2026-10-20
Results first posted: 2025-12-12

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Respiratory-support-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure	up to 28 days	To evaluate whether administration of ganciclovir increases respiratory-support-free days in immunocompetent patients with sepsis-associated acute respiratory failure. The outcome is the number of days the participant is not on respiratory support in the first 28 study days. This outcome uses the last-off approach to calculate the number of respiratory support days. The number of support days after calculated from the last day the participant was on respiratory support.
Secondary	To Evaluate Whether Administration of Ganciclovir Increases Ventilator-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure.	up to 28 study days	During the first 28 study days, the number of days the participants are not on mechanical ventilation using the last off approach is compared between the two treatment arms.
Secondary	To Evaluate Whether Administration of Ganciclovir Increases Total Respiratory-support-free Days (All RSFDS, Instead of Last-off Approach) in Immunocompetent Patients With Sepsis- Associated Acute Respiratory Failure	up to 28 days	During the first 28 study days, the number of days the participants are not on any respiratory-support is compared between the two treatment arms. Instead of using last-off approach, we will count all the days during 28 days period.
Secondary	To Evaluate Whether Mortality and Time to Death in the 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	at study day 28	This is a time to event outcome with death as the event and censoring at the time of study termination if the participant is alive at 28 days. The hazard ratio and Cox proportional hazards models are used for this endpoint.
Secondary	To Evaluate Whether Mortality and Time to Death in the 180 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	at the final study visit (day 180)	This is a time to event outcome with death as the event and censoring at the time of study termination if the participant is alive at the end of the study (day 180).
Secondary	To Evaluate Whether Duration of Mechanical Ventilation Among Survivors in the First 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 28 days	This endpoint summarizes the days of mechanical ventilation for those participants who survive the first 28 days of the study. Participants who die in the first 28 days are excluded.
Secondary	To Evaluate Whether Duration of Respiratory Support Among Survivors in the First 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 28 days	This endpoint summarizes the days of all types of respiratory support for those participants who survive the first 28 days of the study. Participants who die in the first 28 days are excluded.
Secondary	To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 7 days	The PaO2/FiO2 (P/F) ratio was used to define oxygenation. The P/F ratio was summarized over the first 7 days of the study. The lowest PaO2 value within each study day was reported and used in the oxygenation calculation. If the PaO2 value was not available, an estimate of PaO2 was calculated from the SpO2 lowest value.
Secondary	To Evaluate Whether ICU-free Days in the First 28 Days Are Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 28 days	During the first 28 study days, the number of days the participants are not in ICU using the last off approach is compared between the two treatment arms.
Secondary	To Evaluate Whether CMV DNA Detection in Plasma and Endotracheal Aspirate (ETA) by Day 28 is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 28 days	CMV DNA detection in plasma and endotracheal aspirate (ETA) by day 28 is defined as positive CMV PCR result from any ETA, plasma, or serum specimen collected through day 28. CMV reactivation by day 28 will be summarized with number of participants with CMV reactivation in two levels: as any detectable CMV DNA (any level) and as high-level reactivation (\>1000 IU/mL) for CMV negative patients at baseline.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Respiratory-support-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure	up to 28 days	All participants enrolled, eligible, and evaluable (not replaced) and included in this primary analysis.	days	MEAN
SECONDARY	To Evaluate Whether Administration of Ganciclovir Increases Ventilator-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure.	up to 28 study days	Only the participants on mechanical ventilation at study entry are included. Participants on other types of respiratory support are excluded from this endpoint analysis.	days not on mechanical ventilation	MEAN
SECONDARY	To Evaluate Whether Administration of Ganciclovir Increases Total Respiratory-support-free Days (All RSFDS, Instead of Last-off Approach) in Immunocompetent Patients With Sepsis- Associated Acute Respiratory Failure	up to 28 days	All participants enrolled, eligible, and evaluable (not replaced) and included in this primary analysis.	days	MEAN
SECONDARY	To Evaluate Whether Mortality and Time to Death in the 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	at study day 28	Includes all participant enrolled, eligible, and evaluable (not replaced).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate Whether Mortality and Time to Death in the 180 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	at the final study visit (day 180)	Includes all participant enrolled, eligible, and evaluable (not replaced).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Evaluate Whether Duration of Mechanical Ventilation Among Survivors in the First 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 28 days	Only the participants on mechanical ventilation at study entry are included. Participants on other types of respiratory support are excluded from this endpoint analysis.	days on mechanical ventilation	MEAN
SECONDARY	To Evaluate Whether Duration of Respiratory Support Among Survivors in the First 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 28 days	Participants who survive the first 28 days of this study are included.	days on respiratory support	MEAN
SECONDARY	To Evaluate Whether Oxygenation is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 7 days		PaO2/FiO2	MEAN
SECONDARY	To Evaluate Whether ICU-free Days in the First 28 Days Are Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 28 days	All participants enrolled, eligible, and evaluable (not replaced) and included in this primary analysis.	days	MEAN
SECONDARY	To Evaluate Whether CMV DNA Detection in Plasma and Endotracheal Aspirate (ETA) by Day 28 is Different Among Ganciclovir Recipients Relative to Placebo Recipients.	up to 28 days	Participants who tested CMV negative at baseline	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Respiratory-support-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure	IV Ganciclovir	12.1	Standard Deviation 11.1	days
Respiratory-support-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure	Placebo	14.6	Standard Deviation 10.5	days
To Evaluate Whether Administration of Ganciclovir Increases Ventilator-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure.	IV Ganciclovir	11.7	Standard Deviation 11.1	days not on mechanical ventilation
To Evaluate Whether Administration of Ganciclovir Increases Ventilator-free Days in Immunocompetent Patients With Sepsis-associated Acute Respiratory Failure.	Placebo	15.3	Standard Deviation 10.6	days not on mechanical ventilation
To Evaluate Whether Administration of Ganciclovir Increases Total Respiratory-support-free Days (All RSFDS, Instead of Last-off Approach) in Immunocompetent Patients With Sepsis- Associated Acute Respiratory Failure	IV Ganciclovir	12.9	Standard Deviation 11.1	days
To Evaluate Whether Administration of Ganciclovir Increases Total Respiratory-support-free Days (All RSFDS, Instead of Last-off Approach) in Immunocompetent Patients With Sepsis- Associated Acute Respiratory Failure	Placebo	15.2	Standard Deviation 10.2	days
To Evaluate Whether Mortality and Time to Death in the 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	IV Ganciclovir	34		Participants
To Evaluate Whether Mortality and Time to Death in the 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	Placebo	13		Participants
To Evaluate Whether Mortality and Time to Death in the 180 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	IV Ganciclovir	45		Participants
To Evaluate Whether Mortality and Time to Death in the 180 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	Placebo	22		Participants

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IV Ganciclovir	106
Overall Study	STARTED	Placebo	99
Overall Study	COMPLETED	IV Ganciclovir	47
Overall Study	COMPLETED	Placebo	59
Overall Study	NOT COMPLETED	IV Ganciclovir	59
Overall Study	NOT COMPLETED	Placebo	40

Source ClinicalTrials.gov

Adverse events118

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	IV Ganciclovir	1	106	1
other	Anaemia	Blood and lymphatic system disorders	Placebo	0	99	0
other	Coagulopathy	Blood and lymphatic system disorders	IV Ganciclovir	0	106	0
other	Coagulopathy	Blood and lymphatic system disorders	Placebo	1	99	1
other	Eosinophilia	Blood and lymphatic system disorders	IV Ganciclovir	0	106	0
other	Eosinophilia	Blood and lymphatic system disorders	Placebo	1	99	1
other	Thrombocytopenia	Blood and lymphatic system disorders	IV Ganciclovir	1	106	1
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	2	99	2
other	Acute cardiac event	Cardiac disorders	IV Ganciclovir	1	106	1
other	Acute cardiac event	Cardiac disorders	Placebo	0	99	0

1 to 10 of 118Source ClinicalTrials.gov

See all 118 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IV Ganciclovir	45	106
Total, all-cause mortality	Placebo	22	99
Total, other adverse events	IV Ganciclovir	22	106
Total, other adverse events	Placebo	18	99
Total, serious adverse events	IV Ganciclovir	0	106
Total, serious adverse events	Placebo	0	99

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UG3HL147011	1/2 Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients with Acute Respiratory Failure and Sepsis	BOECKH, MICHAEL J; LIMAYE, ABHIJIT PRAKASH; RUBENFELD, GORDON D; STAPLETON, RENEE D	FRED HUTCHINSON CANCER RESEARCH CENTER	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2020

Source NIH RePORTER

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
IV Ganciclovir vs Placebo: To Evaluate Whether Mortality and Time to Death in the 28 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	Trial comparisons
IV Ganciclovir vs Placebo: To Evaluate Whether Mortality and Time to Death in the 180 Days is Different Among Ganciclovir Recipients Relative to Placebo Recipients, Respectively.	Trial comparisons
IV Ganciclovir vs Placebo: deaths from any cause	Trial comparisons
IV Ganciclovir vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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