Rapamune Improves Outcomes of Severe H1N1 Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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

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H1N1 Pneumonia Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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with Rapamune treatment

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.

Group Type ACTIVE_COMPARATOR

Sirolimus (Rapamune 2mg/day, Pfizer)

Intervention Type DRUG

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

Without Rapamune treatment.

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.

Group Type PLACEBO_COMPARATOR

Sirolimus (Rapamune 2mg/day, Pfizer)

Intervention Type DRUG

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

Interventions

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Sirolimus (Rapamune 2mg/day, Pfizer)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* H1N1 patients with severe hypoxemia \[alveolar-arterial oxygen gradient, (A-a) O2 gradient, \> 200 mmHg\] requiring ventilator support were included to randomization.