Influenza Virus - A Multicenter Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Alberta.
Recruitment status was  Recruiting
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

December 6, 2010
April 20, 2012
November 2010
May 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01256255 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Influenza Virus - A Multicenter Registry
INFLUENZA VIRUS INFECTIONS IN TRANSPLANT RECIPIENTS: A MULTICENTER REGISTRY

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum and nasal swabs

Non-Probability Sample

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

Influenza Infection in Transplant Patients
Not Provided
influenza infection
Patients with the diagnosis of influenza infection by standard laboratory technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2013
May 2013   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact: Leticia Wilson, Msc 780492-3885 lely@ualberta.ca
Canada
 
NCT01256255
UOA-FLU-2010-11
No
Deepali Kumar, University of Alberta
University of Alberta
Not Provided
Principal Investigator: Deepali Kumar, MD University of Alberta
University of Alberta
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP