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Study of Ganciclovir/Valganciclovir for Prevention of Cytomegalovirus Reactivation in Acute Injury of the Lung and Respiratory Failure (GRAIL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01335932
First Posted: April 15, 2011
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Genentech, Inc.
Information provided by (Responsible Party):
Michael Boeckh, Fred Hutchinson Cancer Research Center
Results First Submitted: June 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome
Respiratory Failure
Interventions: Drug: IV Ganciclovir
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IV Ganciclovir

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

Placebo

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.


Participant Flow:   Overall Study
    IV Ganciclovir   Placebo
STARTED   84   76 
COMPLETED   84   72 
NOT COMPLETED   0   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IV Ganciclovir

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

Placebo

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.

The placebo is an IV solution that does not contain any active medications.

Total Total of all reporting groups

Baseline Measures
   IV Ganciclovir   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 84   76   160 
Age 
[Units: Years]
Mean (Full Range)
 55.2 
 (18 to 95) 
 58.2 
 (18 to 95) 
 56.6 
 (18 to 95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      35  41.7%      36  47.4%      71  44.4% 
Male      49  58.3%      40  52.6%      89  55.6% 
Region of Enrollment 
[Units: Participants]
     
United States   84   76   160 


  Outcome Measures

1.  Primary:   Serum IL-6 Level   [ Time Frame: Baseline and Day 14 ]

2.  Secondary:   Incidence of CMV Reactivation at 28 Days (Blood, Throat)   [ Time Frame: at 28 days post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Additional Cytokine Levels   [ Time Frame: at 7 and 28 days post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Clinical Outcomes   [ Time Frame: at 7, 14, 28, 60, and 180 days post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Length of Stay   [ Time Frame: by 28 and 180 days post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   CMV Disease   [ Time Frame: by 180 days post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Safety   [ Time Frame: by 35 days post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Functional Assessment   [ Time Frame: at 1 and 180 days post-randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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)


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr.Michael Boeckh
Organization: FHCRC
phone: 206 667-6706
e-mail: mboeckh@fredhutch.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Boeckh, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01335932     History of Changes
Other Study ID Numbers: 7217
U01HL102547 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2011
First Posted: April 15, 2011
Results First Submitted: June 21, 2017
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017