Rapamune Improves Outcomes of Severe H1N1 Pneumonia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
H1N1 Pneumonia Hypoxemia |
Drug: Sirolimus (Rapamune 2mg/day, Pfizer) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adjuvant Treatment With a mTOR Inhibitor, Rapamune Improves Outcomes of Severe H1N1 Pneumonia With Acute Respiratory Failure |
- liberation of ventilator [ Time Frame: 28 days ] [ Designated as safety issue: No ]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.
- necessity of Extracorporeal membrane oxygenation(ECMO) [ Time Frame: 28 days ] [ Designated as safety issue: No ]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
| Enrollment: | 38 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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. |
Drug: Sirolimus (Rapamune 2mg/day, Pfizer)
Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days.
|
|
Placebo Comparator: 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. |
Drug: Sirolimus (Rapamune 2mg/day, Pfizer)
Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Chung Fu-Tsai, Attending physician, Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01620307 History of Changes |
| Other Study ID Numbers: | IRB:100-2433C |
| Study First Received: | June 13, 2012 |
| Last Updated: | June 14, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Chang Gung Memorial Hospital:
|
H1N1 patients with severe hypoxemia requiring ventilator support |
Additional relevant MeSH terms:
|
Pneumonia Anoxia Respiratory Insufficiency Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms, Respiratory Signs and Symptoms Respiration Disorders Sirolimus Everolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013