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Influenza Virus - A Multicenter Registry

This study is currently recruiting participants.
Verified April 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta
ClinicalTrials.gov Identifier:
NCT01256255
First received: December 6, 2010
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition
Influenza Infection in Transplant Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: INFLUENZA VIRUS INFECTIONS IN TRANSPLANT RECIPIENTS: A MULTICENTER REGISTRY

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

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 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256255

Contacts
Contact: Leticia Wilson, Msc 780492-3885 lely@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2E1
Contact: Leticia Wilson, Msc     780-492-3885     lely@ualberta.ca    
Principal Investigator: Deepali Kumar, MD            
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Deepali Kumar, MD University of Alberta
  More Information

No publications provided

Responsible Party: Deepali Kumar, Assistant Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT01256255     History of Changes
Other Study ID Numbers: UOA-FLU-2010-11
Study First Received: December 6, 2010
Last Updated: April 20, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
transplant
influenza infection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013