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Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure
NCT01335932 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2011-03-10 |
| Est. Completion | 2016-10-28 |
| Phase | Phase 2 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 319 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01335932 reports 14 study locations spanning 11 distinct geographic areas — top geographies include Ohio, Pennsylvania, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01335932?
The interventions under investigation include: Placebo (DRUG), IV Ganciclovir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01335932?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 319 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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