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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01620307
Other study ID # IRB:100-2433C
Secondary ID
Status Completed
Phase Phase 2
First received June 13, 2012
Last updated June 14, 2012
Start date June 2009
Est. completion date December 2011

Study information

Verified date June 2012
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary necessity of Extracorporeal membrane oxygenation(ECMO) 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 28 days No
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