NCT01620307

Rapamune Improves Outcomes of Severe H1N1 Pneumonia

Adjuvant Treatment With a mTOR Inhibitor, Rapamune Improves Outcomes of Severe H1N1 Pneumonia With Acute Respiratory Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

From 2009 winter to 2011 spring, patients with flu-like symptoms in Chang Gung Memorial Hospital were screened by rapid antigen test and influenza subtype was confirmed by polymerization chain reaction (PCR). 38 H1N1 patients with severe hypoxemia \[alveolar-arterial oxygen gradient, (A-a) O2 gradient, \> 200 mmHg\] requiring ventilator support were randomized to receive Rapamune (2mg/day) or not. Patients were then randomized to receive either Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days. The outcome variables include liberation of ventilator, ICU mortality, necessity of ECMO, Sequential Organ Failure Assessment (SOFA) score and complications after admission to ICU were recorded. SOFA score composed of scores from six organ systems, graded from 0 to 4 according to the degree of dysfunction/failure.

Conditions

• H1N1 Pneumonia
• Hypoxemia

Interventions

Type	Name	Description
DRUG	Sirolimus (Rapamune 2mg/day, Pfizer)	Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-07-01
• Completion: 2011-12-01
• First posted: 2012-06-15
• Last updated: 2012-06-15