INFLUENZA VIRUS INFECTIONS IN TRANSPLANT RECIPIENTS: A MULTICENTER REGISTRY

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