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NCT01335932 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Respiratory Failure and Acute Respiratory Distress Syndrome, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 2
Development phase
160
Enrollment target
14
Study locations

NCT01335932: Completed Phase 2 study of Respiratory Failure and Acute Respiratory Distress Syndrome, sponsored by Fred Hutchinson Cancer Center.

NCT01335932 is a Phase 2 study of Respiratory Failure and Acute Respiratory Distress Syndrome that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 160 participants, below the 4,520-participant average among 40 other Respiratory Failure trials with a reported enrollment target (96% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01335932, a Phase 2 study of Respiratory Failure and Acute Respiratory Distress Syndrome, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
160 participants
Enrollment target
14
Study locations

Study Summary

To evaluate whether administration of ganciclovir reduces serum IL-6 levels (i.e. reduction between baseline and 14 days post-randomization) in immunocompetent adults with severe sepsis or trauma associated respiratory failure. Primary Hypotheses: \- In CMV seropositive adults with severe sepsis or trauma , pulmonary and systemic CMV reactivation amplifies and perpetuates both lung and systemic inflammation mediated through specific cytokines, and contributes to pulmonary injury and multiorgan system failure, AND \- Prevention of CMV reactivation with ganciclovir decreases pulmonary and systemic inflammatory cytokines that are important in the pathogenesis of sepsis and trauma related complications.

Primary Outcome

Change between baseline and 14 days post-randomization between placebo \& ganciclovir groups

Conditions Studied

Respiratory Failure Acute Respiratory Distress Syndrome Acute Lung Injury

Interventions

  • DRUG Placebo
  • DRUG IV Ganciclovir

Study Locations (14)

Ohio

  • The Cleveland Clinic Foundation - Cleveland
  • Ohio State University Medical Center - Columbus

Pennsylvania

  • University of Pennsylvania Medical Center - Philadelphia
  • University of Pittsburgh Medical Center - Pittsburgh

Washington

  • Harborview Medical Center - Seattle
  • University of Washington Medical Center / Harborview Medical Center - Seattle

Colorado

  • University of Colorado / National Jewish Health / Swedish Medical Center - Denver

Illinois

  • Northwestern University - Chicago

Massachusetts

  • Baystate Critical Care Medicine / Tufts University School of Medicine - Springfield

Michigan

  • University of Michigan - Ann Arbor

North Carolina

  • Wakeforest University, School of Medicine - Winston-Salem

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2011-03-10
Est. Completion 2016-10-28
Phase Phase 2
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT01335932 record still lists

NCT01335932 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 4,520-participant average among 40 other Respiratory Failure trials with a reported enrollment target (96% lower).

The record links to 3 conditions, with Respiratory Failure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01335932 lists 14 locations in 11 states (Ohio, Pennsylvania, Washington).

Frequently Asked Questions

What is clinical trial NCT01335932 about?

NCT01335932 is a clinical study titled "Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure". To evaluate whether administration of ganciclovir reduces serum IL-6 levels (i.e. reduction between baseline and 14 days post-randomization) in immunocompetent adults with severe sepsis or trauma associated respiratory failure. Primary Hypotheses: \- In CMV seropositive adults with severe sepsis o...

What is the current status of trial NCT01335932?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2011-03-10. Estimated completion is 2016-10-28.

What conditions does trial NCT01335932 study?

This clinical trial studies the following conditions: Respiratory Failure, Acute Respiratory Distress Syndrome, Acute Lung Injury.

What interventions are being tested in trial NCT01335932?

The interventions under investigation include: Placebo (DRUG), IV Ganciclovir (DRUG).

Who is sponsoring clinical trial NCT01335932?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01335932 being conducted?

This trial has 14 study locations across Colorado, Illinois, Massachusetts, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Respiratory Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01335932's enrollment target sits among peer trials

160 18th of 40 higher than 23 of 40 other Respiratory Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Respiratory Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01335932, the US trial registry maintained by the National Library of Medicine. NCT01335932 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.