NCT01620307|CompletedPhase 2DMC
Rapamune Improves Outcomes of Severe H1N1 Pneumonia
Adjuvant Treatment With a mTOR Inhibitor, Rapamune Improves Outcomes of Severe H1N1 Pneumonia With Acute Respiratory Failure
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Sponsor study identifier
interventional
38
0 countries
N/A
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Severe H1N1 pneumonia with acute respiratory failure shows hyperactive immune cells infiltration of lung. Rapamune, a mTOR inhibitor, modulates the immune response by blocking activation of T- and B-cells. To investigate the clinical efficiency of rapamune in severe H1N1 pneumonia with respiratory failure, this study was conducted.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 2011
Actual (reported)December 2011
Actual (reported)June 13, 2012
Actual (reported)June 15, 2012
Actual (reported)liberation of ventilator
Patients were then randomized to receive either Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days. Ventilator management was previously described. The ventilator liberation rate is primary outcome.
28 days
necessity of Extracorporeal membrane oxygenation(ECMO)
28 days
All patients were treated with Oseltamivir (Tamiflu, Roche) 50 mg twice a day for 10 days and oral prednisolone 20 mg/day for 14 days. At ICU admission, patients started on empiric antimicrobial therapy with moxifloxacin 500 mg per day until results of microbiological studies were available. Each patient received best support treatment including mechanical ventilator, fluid resuscitation, gastrointestinal and thromboembolic prophylaxis, and enteral nutrition for most aspects of care. After radomization, patients were received Sirolimus (Rapamune 2mg/day, Pfizer)for a course of 14 days.
All patients were treated with Oseltamivir (Tamiflu, Roche) 50 mg twice a day for 10 days and oral prednisolone 20 mg/day for 14 days. At ICU admission, patients started on empiric antimicrobial therapy with moxifloxacin 500 mg per day until results of microbiological studies were available. Each patient received best support treatment including mechanical ventilator, fluid resuscitation, gastrointestinal and thromboembolic prophylaxis, and enteral nutrition for most aspects of care. After radomization, patients were not to receive Sirolimus (Rapamune 2mg/day, Pfizer)for a course of 14 days.
Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Tsang-Tang Hsieh, MD
Chang Gung Memorial Hospital
38 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2012
First Posted
June 15, 2012
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
Contact the study team to confirm eligibility.
Primary Completion
July 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
June 15, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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