Trial · NCT01335932

Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure

NCT01335932, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2017-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure. Trials, record NCT01335932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01335932

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Trial

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

Title: Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure
NCT number: NCT01335932
Status: Completed
Phases: Phase 2
Enrollment: 160 participants, actual
Lead sponsor: Fred Hutchinson Cancer Center
Conditions: Acute Lung Injury, Acute Respiratory Distress Syndrome, Respiratory Failure
Interventions: IV Ganciclovir, Placebo
First posted: 2011-04-15
Last updated: 2018-08-21
Results first posted: 2017-09-13
Limitations and caveats: Inclusion of too few trauma patients to assess treatment effects, a long enrollment window length, discontinuation of BAL sampling due to feasibility and changes in oral drug availability (later part of the study)

Source ClinicalTrials.gov

Registered outcomes67

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

List	Outcome	Time frame	Description
Primary	Serum IL-6 Level	Baseline and Day 14	Change between baseline and 14 days post-randomization between placebo \& ganciclovir groups
Secondary	Number of Participants With CMV Reactivation at 28 Days in Plasma	at 28 days post-randomization	Number of participants in baseline negatives with CMV reactivation at any level at day 28
Secondary	BAL Levels of IL-6	at 7 days post-randomization	Levels of IL-6 from BALs at 7 days post-randomization
Secondary	Number of Participants With Organ System Failure at 14 Days	at 14 days post-randomization	Number of participants experiencing organ system failure at 14 days
Secondary	Number of Days Alive and Not in the ICU	by 28 days post-randomization	Number of ICU days alive and not in the ICU by day 28
Secondary	CMV Disease	by 180 days post-randomization	Need to be biopsy-proven
Secondary	Grade 3 AEs or Higher	by 35 days post-randomization	Number of patients with greater than one AE of grade 3 or more
Secondary	SF-36 Health Survey	at 1 day post-randomization	Physical Component Summary of SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Secondary	Incidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasma	at 28 days post-randomization	Number of participants with CMV reactivation \>1,000 IU per mL at day 28 in plasma
Secondary	Incidence of CMV Reactivation at Any Level at 28 Days in Throat	at 28 days post-randomization	CMV reactivation in baseline negatives at any level at day 28 in throat

1 to 10 of 67Source ClinicalTrials.gov

See all 67 registered outcomes

Outcomes67

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Serum IL-6 Level	Baseline and Day 14		pg/mL	MEAN
SECONDARY	Number of Participants With CMV Reactivation at 28 Days in Plasma	at 28 days post-randomization		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	BAL Levels of IL-6	at 7 days post-randomization	The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.	log 10 pg/mL	MEAN
SECONDARY	Number of Participants With Organ System Failure at 14 Days	at 14 days post-randomization		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Days Alive and Not in the ICU	by 28 days post-randomization		days	MEAN
SECONDARY	CMV Disease	by 180 days post-randomization		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Grade 3 AEs or Higher	by 35 days post-randomization		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	SF-36 Health Survey	at 1 day post-randomization		scores on a scale	MEAN
SECONDARY	Incidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasma	at 28 days post-randomization		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of CMV Reactivation at Any Level at 28 Days in Throat	at 28 days post-randomization		Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 67Source ClinicalTrials.gov

See all 67 outcomes

Results by group172

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

Outcome	Group	Category	Value	Spread	Units
Serum IL-6 Level	IV Ganciclovir		-0.79	Standard Deviation 0.65	pg/mL
Serum IL-6 Level	Placebo		-0.79	Standard Deviation 0.69	pg/mL
Number of Participants With CMV Reactivation at 28 Days in Plasma	IV Ganciclovir	CMV viremia at any level	3		Participants
Number of Participants With CMV Reactivation at 28 Days in Plasma	Placebo	CMV viremia at any level	23		Participants
Number of Participants With CMV Reactivation at 28 Days in Plasma	IV Ganciclovir	no CMV viremia at any level	74		Participants
Number of Participants With CMV Reactivation at 28 Days in Plasma	Placebo	no CMV viremia at any level	44		Participants
BAL Levels of IL-6	IV Ganciclovir		1.01	Standard Deviation 0.78	log 10 pg/mL
BAL Levels of IL-6	Placebo		1.66	Standard Deviation 1.26	log 10 pg/mL
Number of Participants With Organ System Failure at 14 Days	IV Ganciclovir	with organ failure	0		Participants
Number of Participants With Organ System Failure at 14 Days	Placebo	with organ failure	2		Participants

1 to 10 of 172Source ClinicalTrials.gov

See all 172 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	84
Overall Study	STARTED	Placebo	76
Overall Study	COMPLETED	IV Ganciclovir	84
Overall Study	COMPLETED	Placebo	72
Overall Study	NOT COMPLETED	IV Ganciclovir	0
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events0

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

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IV Ganciclovir	10	84
Total, all-cause mortality	Placebo	11	72
Total, other adverse events	IV Ganciclovir	0	84
Total, other adverse events	Placebo	0	72
Total, serious adverse events	IV Ganciclovir	0	84
Total, serious adverse events	Placebo	0	72

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28829877	RESULT

Source PubMed

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
U01HL102547	A Randomzied Phase II Trial of CMV Prevention in Acute Lung Injury	BOECKH, MICHAEL J; LIMAYE, ABHIJIT PRAKASH; RUBENFELD, GORDON D	FRED HUTCHINSON CANCER RESEARCH CENTER	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2010 to 2014

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
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.

For software

Read this trial from software.

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

GET https://conductscience.org/api/trials/v1/NCT01335932

GET https://conductscience.org/api/trials/v1/NCT01335932/registered?page=2

API reference For AI assistants