Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01256255 |
| Other study ID # |
UOA-FLU-2010-11 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2010 |
| Est. completion date |
January 27, 2014 |
Study information
| Verified date |
May 2022 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The investigators purpose is to prospectively characterize influenza infections over a 3 year
period in transplant patients using a registry system. The investigators plan to generate
robust data on clinical features of upper and lower respiratory disease, antiviral therapy
and its effects on disease outcome, as well as quantitative virologic data on shedding and
antiviral resistance. The investigators also will study the long term sequelae of influenza
infections and look at development of rejection.
Description:
This study will be a prospective, multi-center study conducted at investigator sites who
comprise the Influenza in Transplant collaborative study group. This includes over 30 centers
from across North America and Europe. The co-ordinating center will be the University of
Alberta. We will aim to enrol 300 patients in the registry over a 3 year period.
The following information will be gathered:
1. Clinical Information
- Baseline demographic information about the transplant (including immunosuppression,
graft function)
- Comorbidities such as diabetes, obesity, chronic lung disease
- Symptoms of infection, radiologic features of infections
- Antiviral use
- History of vaccination
- Outcomes such as hospitalization, ICU admission, mechanical ventilation, death
- Long term outcomes: allograft function, chronic respiratory disease
- Laboratory parameters including lymphocyte count, immunoglobulin levels, renal
function
- Adverse events - all serious adverse events occurring during the study (till day
180) will be reported. These include: a) hospitalization; b) congenital deformity;
c) death; d) disability; and e) other adverse events the investigator considers
serious. Pregnancy during the follow-up period will also be reported.
2. Virology
- Method of diagnosis (DFA, viral culture, PCR)
- Subtype of influenza virus (ie HxNx)
- Viral Shedding by serial NP swabs at day 0 (diagnosis), 3, 6, 11, 18, 28 (weekly
thereafter if shedding persists)
- Quantitative PCR of NP swabs (centrally at University of Alberta)
- Antiviral resistance testing at first and last positive swabs
3. Immunology - Serum collection at disease onset and 4-6 weeks afterwards for
- Serology against circulating influenza viruses
- Production of HLA alloantibodies
Significance:
Despite the recognized importance of influenza in transplant patients, there is actually very
limited prospective data. This registry will represent the largest prospective data
collection on influenza in transplant patients and will provide invaluable data on the
clinical presentations, antiviral efficacy and other parameters related to influenza.
