Invasive Fungal InfectionsNCT01519648
A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation
An observational study of Invasive Fungal Infections, run by National Hematological Society, Russia at 1 site in Russia.
Trial summary
Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation. Read more about this study
- Who is it for?
- Ages 1 year to 95 years
- Conditions the study is for
- Invasive Fungal Infections
- How many people
- 808 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2012to Mar 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 1 year to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This observational study will be implemented in the hematology departments or hematology centers with or without HSCT located throughout Russia.
Who may be able to join
- Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy
- All newly allogeneic or autologous transplant recipients during the study period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.
Read the detailed description
This multi-center observational study of IFI in high risk hematological patients, the study will investigate the epidemiology of IFI, describe antifungal strategy, proportion of antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk patients.
- Conditions
- Invasive Fungal Infections
- Keywords
- Invasive fungal infection, Acute leukemia (AL), Hematopoietic stem cell transplantation, Antifungal stewardship, Neutropenia, Hematological malignancies
- Medical subject headings
- Invasive Fungal Infections, Neutropenia, Hematologic Neoplasms
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 |
|---|---|---|
| Acute leukemia patients | Patients with de novo or relapsed acute myeloid and lymphoid leukemia | |
| Allo- or auto- transplant recipients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Invasive Fungal Infections
Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionMar 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 Invasive Fungal InfectionsStudies of the same condition, open and under way.
- 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
- 808 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hematological Society, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Galina A Klyasova, Principal investigator, National Research Center for Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519648
- Sponsor's protocol ID
- RIFI
- Status last verified
- Jul 2014
- First submitted
- 23 Jan 2012
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01519648
- Acronym / sponsor ID
- RIFI
- Conditions
- Invasive Fungal Infections
- Keywords
- Invasive fungal infection, Acute leukemia (AL), Hematopoietic stem cell transplantation, Antifungal stewardship, Neutropenia, Hematological malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 808 participants (actual)
- Lead sponsor
- National Hematological Society, RussiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Posted 18 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.
Detailed description
This multi-center observational study of IFI in high risk hematological patients, the study will investigate the epidemiology of IFI, describe antifungal strategy, proportion of antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute leukemia patients | – | –Patients with de novo or relapsed acute myeloid and lymphoid leukemia |
| Allo- or auto- transplant recipients | – | – |
Who may qualify
- Ages
- 1 year to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This observational study will be implemented in the hematology departments or hematology centers with or without HSCT located throughout Russia.
Key inclusion criteria (2 listed)
- Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy
- All newly allogeneic or autologous transplant recipients during the study period
Key exclusion criteria (0 listed)
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
The Rate of Invasive Fungal Infections
Time frame: 6 month
Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- 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.
Galina A Klyasova principal investigator
National Research Center for Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections, run by National Hematological Society, Russia at 1 site in Russia.
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 0 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 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2014). 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?
The Rate of Invasive Fungal Infections (time frame: 6 month). 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 25 Jul 2014.