Influenza A
Conditions
Keywords
Influenza A, convalescent plasma, death
Brief summary
Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.
Detailed description
Patients presented with severe 2009 H1N1 infection responded poorly to antiviral agents. Meta-analysis of reports from 1918 H1N1 pandemic suggested that convalescent plasma might be an effective treatment option for patients with severe 2009 H1N1 infection.
Interventions
DRUGH1N1 convalescent plasma and oseltamivir
Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing \>= 1:160 of neutralizing antibody to Pandemic influenza A H1N1
DRUGOral Oseltamivir alone
Oral Oseltamivir 75mg bid during ICU hospitalization
Sponsors
The University of Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients ≥ 18 years old with written informed consent given by patient or next-of-kin * laboratory confirmatory diagnosis of 2009 H1N1 infection by positive RT-PCR from respiratory specimens * required intensive care within 7 days of onset of symptoms
Exclusion criteria
* age 18 years old or below * known hypersensitivity to immune globulin * known IgA deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | Participants are followed until death or discharge from ICU (average 2 weeks) | mortality during hospitalization directly related to H1N1 2009 infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in ICU | Participants are followed until death or discharge from ICU (average 2 weeks) | days of stay in ICU |
| Adverse events secondary to the convalescent plasma treatment | Participants are followed until death or discharge from ICU (average 2 weeks) | Allergic reaction (including anaphylaxis), acute renal failure, fluid overload |
| Complication | Participants are followed until death or discharge from ICU (average 2 weeks) | including pneumonia, ARDS, renal failure, heart failure and secondary infection |
| Change in viral load | Participants are followed until death or discharge from ICU (average 2 weeks) | Daily measurement of H1N1 2009 viral load |
| Change in cytokine level | Participants are followed until death or discharge from ICU (average 2 weeks) | daily measurement of cytokine level (serum) |
| Time on respiratory support | Participants are followed until death or discharge from ICU (average 2 weeks) | including ventilator, CPAP and BiPAP |
Countries
China
Outcome results
None listed