Influenza Virus - A Multicenter Registry

NCT ID: NCT01256255

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 282 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-01-27

Brief Summary

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

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.

Conditions

Influenza Infection in Transplant Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

influenza infection

Patients with the diagnosis of influenza infection by standard laboratory technique

No interventions assigned to this group

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deepali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

References

L'Huillier AG, Ferreira VH, Hirzel C, Cordero E, Limaye AP, Reid G, Englund J, Blumberg E, Kumar D, Humar A. Cytokine Profiles and Severity of Influenza Infection in Transplant Recipients. J Infect Dis. 2019 Jan 29;219(4):535-539. doi: 10.1093/infdis/jiy535.

Reference Type: DERIVED

PMID: 30192949 (View on PubMed)

Other Identifiers

UOA-FLU-2010-11

Identifier Type: -

Identifier Source: org_study_id