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Rapamune Improves Outcomes of Severe H1N1 Pneumonia

Information source: Chang Gung Memorial Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: H1N1 Pneumonia; Hypoxemia

Intervention: Sirolimus (Rapamune 2mg/day, Pfizer) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Chang Gung Memorial Hospital

Official(s) and/or principal investigator(s):
Tsang-Tang Hsieh, MD, Study Chair, Affiliation: Chang Gung Memorial Hospital


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: liberation of ventilator

Secondary outcome: necessity of Extracorporeal membrane oxygenation(ECMO)

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.


Minimum age: 20 Years. Maximum age: 90 Years. Gender(s): Both.


Inclusion Criteria:

- H1N1 patients with severe hypoxemia [alveolar-arterial oxygen gradient, (A-a) O2

gradient, > 200 mmHg] requiring ventilator support were included to randomization. Exclusion Criteria:

- severity of illness and multiple organ dysfunction (MOD) were assessed within 24

hours of ICU admission.

Locations and Contacts

Additional Information

Starting date: June 2009
Last updated: June 14, 2012

Page last updated: August 23, 2015

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