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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 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.

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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.

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

Sponsor

Fred Hutchinson Cancer Center

483 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01335932

The ClinicalTrials.gov registry entry for NCT01335932 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,520-participant average among 40 other Respiratory Failure trials with a reported enrollment target (96% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.