Influenza Virus - A Multicenter Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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 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.

Official Title
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INFLUENZA VIRUS INFECTIONS IN TRANSPLANT RECIPIENTS: A MULTICENTER REGISTRY

Conditions
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Influenza Infection in Transplant Patients

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid organ transplant recipients on at least one immunosuppressive medication Hematopoietic stem cell transplant recipients - allogeneic or autologous Pediatric or Adult Diagnosis of influenza infection by standard laboratory technique Exclusion Criteria: not able to comply with the protocol
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| influenza infection<br>Patients with the diagnosis of influenza infection by standard laboratory technique | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplant, influenza infection