Influenza Virus - A Multicenter Registry

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta Identifier:
First received: December 6, 2010
Last updated: May 26, 2015
Last verified: May 2015
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.

Influenza Infection in Transplant Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Biospecimen Retention:   Samples Without DNA
serum and nasal swabs

Estimated Enrollment: 300
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
influenza infection
Patients with the diagnosis of influenza infection by standard laboratory technique

Detailed 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


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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Solid organ transplant recipients on at least one immunosuppressive medication and Hematopoietic stem cell transplant recipients (allogeneic or autologous) with the diagnosis of influenza infection by standard laboratory technique

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01256255

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Principal Investigator: Deepali Kumar, MD University of Alberta
  More Information

No publications provided

Responsible Party: Deepali Kumar, Assistant Professor of Medicine, University of Alberta Identifier: NCT01256255     History of Changes
Other Study ID Numbers: UOA-FLU-2010-11
Study First Received: December 6, 2010
Last Updated: May 26, 2015
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
influenza infection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases processed this record on November 30, 2015