MycosesTRAFICNCT01254318
Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)
An observational study of Mycoses and Leukemia, run by Merck Sharp & Dohme LLC.
Trial summary
This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. Read more about this study
- Who is it for?
- Any age
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Nov 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Participants at high risk for IFI at medical institutions in Canada
Who may be able to join
- To be eligible for study inclusion, the participant must have:
- A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant
Who cannot join
- The participant is not eligible for study inclusion if:
- Their IFI is not related to hematological malignancies.
About this study
Official title: Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)
This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.
- Being tested
- Standard Care
- Keywords
- hematological malignancy, fungal infection, leukemia
- Medical subject headings
- Mycoses, Leukemia, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.
| Study group | Role | What they receive |
|---|---|---|
| Participants at high risk for IFI | Participants will be considered high risk if they are undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution
Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.
Measured: 365 days
Secondary outcomes (2)
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution
Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.
Measured: 365 days
Percentage of Participants With Invasive Fungal Infections in Canada
Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startMar 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MycosesStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254318
- Sponsor's protocol ID
- P07501
- Other IDs
- MK-5592-071
- Acronym
- TRAFIC
- Status last verified
- Sep 2016
- First submitted
- 5 Nov 2010
- Last updated
- 2 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)
- ClinicalTrials.gov ID
- NCT01254318
- Acronym / sponsor ID
- TRAFIC / P07501
- Keywords
- hematological malignancy, fungal infection, leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Posted 2 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants at high risk for IFI | – | Other: Standard CareParticipants will be considered high risk if they are undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants at high risk for IFI at medical institutions in Canada
Key inclusion criteria (2 listed)
- To be eligible for study inclusion, the participant must have:
- A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant
Key exclusion criteria (2 listed)
- The participant is not eligible for study inclusion if:
- Their IFI is not related to hematological malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CareHealth-care interventions will be recorded; no additional procedures outside the standard of care will be required. | Other | Participants at high risk for IFI |
Primary outcome
Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution
Time frame: 365 days
Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.
2 secondary outcomes
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution
Time frame: 365 days
Percentage of Participants With Invasive Fungal Infections in Canada
Time frame: 365 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Mycoses and Leukemia, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 2 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 2 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.