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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01620307

Enrollment

Registered

2012-06-15

Start date

2009-06-30

Completion date

2011-12-31

Last updated

2012-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H1N1 Pneumonia, Hypoxemia

Keywords

H1N1 patients with severe hypoxemia requiring ventilator support

Brief 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.

Interventions

DRUGSirolimus (Rapamune 2mg/day, Pfizer)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
liberation of ventilator	28 days	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.

Secondary

Measure	Time frame	Description
necessity of Extracorporeal membrane oxygenation(ECMO)	28 days	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.Extracorporeal membrane oxygenation (ECMO) was used in patients with severe refractory hypoxemia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026