Influenza Infection in Transplant PatientsNCT01256255
Influenza Virus - A Multicenter Registry
An observational study of Influenza Infection in Transplant Patients, run by University of Alberta at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza Infection in Transplant Patients
- How many people
- 282 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2010to 27 Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- not able to comply with the protocol
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2E1
University of Alberta Hospital
Edmonton, Alberta
About this study
Official title: 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.
Read the 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:
- 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.
- Keywords
- transplant, influenza infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| influenza infection | Patients with the diagnosis of influenza infection by standard laboratory technique |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startNov 2010
- Primary completion31 Aug 2013
- Study completion27 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza Infection in Transplant PatientsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepali Kumar, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256255
- Sponsor's protocol ID
- UOA-FLU-2010-11
- Status last verified
- May 2022
- First submitted
- 6 Dec 2010
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30192949
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFLUENZA VIRUS INFECTIONS IN TRANSPLANT RECIPIENTS: A MULTICENTER REGISTRY
- ClinicalTrials.gov ID
- NCT01256255
- Acronym / sponsor ID
- UOA-FLU-2010-11
- Keywords
- transplant, influenza infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- 31 Aug 2013 (actual)
- Study completion
- 27 Jan 2014 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| influenza infection | – | –Patients with the diagnosis of influenza infection by standard laboratory technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- not able to comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 30192949L'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepali Kumar, MD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Infection in Transplant Patients, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.