Antifungal ProphylaxisOLYMPENCT02127788
Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology
An observational study of Antifungal Prophylaxis and Haemopathy, run by Astellas Pharma S.A.S. at 17 sites in France.
Trial summary
The purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antifungal Prophylaxis, Haemopathy
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 17 sitesFrance
- Study dates
- 3 Jul 2014to 27 Jan 2016
- 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: Hospitalized, adult patients with haemopathy or paediatric patients with haemopathy or solid tumor, under antifungal prophylaxis with micafungin.
Who may be able to join
- Adult patient with haemopathy or paediatric patients with haemopathy or solid tumor.
- Patient hospitalized in haematology, onco-haematology or onco-paediatrics unit.
- Patient initiating antifungal prophylaxis with micafungin.
Who cannot join
- Patient presenting documented fungal infection.
- Patient already included in a biomedical study impacting the care management of invasive fungal infection at the time of inclusion.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Site
Angers, 44933
Site
Angers, 49933
Site
Béziers, 34525
Site
Bordeaux, 33076
Site
Brest, 29609
Site
Clermont-Ferrand, 63003
Site
Lille, 59037
Site
Limoges, 37042
Site
Marseille, 13273
Site
Marseille, 13385
Site
Metz, 57038
Site
Montpellier, 34295
Site
Nantes, 44093
Site
Paris, 75012
Site
Paris, 75019
Site
Saint-Denis La Réunion, 97400
Site
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Observational, Longitudinal, Prospective, French, Multicentre Study Conducted on Adult and Paediatric Patients Treated With Micafungin in Prophylaxis and Followed Over a 3 Months' Period in Routine Medical Practice
The purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described.
- Conditions
- Antifungal Prophylaxis, Haemopathy
- Being tested
- Micafungin
- Keywords
- Haematology, Micafungin, Observational study, Prophylaxis, Invasive Fungal Infection, France
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called FK463, Mycamine
intravenous
| Study group | Role | What they receive |
|---|---|---|
| Micafungin | Patients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin. Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breakthrough incidence of Invasive Fungal Infection (IFI), defined according to the revised EORTC/MSG criteria, during prophylaxis use of micafungin
EORTC/MSG : European Organization for Research and Treatment of Cancer/ Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group
Measured: Up to 3 months
Secondary outcomes (6)
Odds ratio and 95% CI for each identified risk factors
Measured: Up to 3 months
Incidence of IFI, defined according to the revised EORTC/MSG criteria
Measured: Up to 3 months
Characteristics of patients treated with micafungin
Measured: Day 0 (start of prophylaxis)
Conditions of use of micafungin
dose and administration pattern, temporary interruptions and treatment duration, oral treatment take-over
Measured: Up to 3 months
Description of adverse events (AE) and serious adverse events (SAE)
Measured: Up to 3 months
Characteristics of units
participating physicians (age, status, specialty), type of institution, location , type of unit, size of unit
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study start3 Jul 2014
- Primary completion27 Jan 2016
- Study completion27 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antifungal ProphylaxisStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical and Scientific Affairs Manager, Infectious Diseases, Study director, Astellas Pharma S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127788
- Sponsor's protocol ID
- FR-MYC-NI-003
- Acronym
- OLYMPE
- Status last verified
- Mar 2019
- First submitted
- 17 Apr 2014
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Longitudinal, Prospective, French, Multicentre Study Conducted on Adult and Paediatric Patients Treated With Micafungin in Prophylaxis and Followed Over a 3 Months' Period in Routine Medical Practice
- ClinicalTrials.gov ID
- NCT02127788
- Acronym / sponsor ID
- OLYMPE / FR-MYC-NI-003
- Conditions
- Antifungal Prophylaxis, Haemopathy
- Keywords
- Haematology, Micafungin, Observational study, Prophylaxis, Invasive Fungal Infection, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Astellas Pharma S.A.S.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2014 (actual)
- Primary completion
- 27 Jan 2016 (actual)
- Study completion
- 27 Jan 2016 (actual)
- First posted
- 1 May 2014 (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 purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micafungin | – | Drug: MicafunginPatients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized, adult patients with haemopathy or paediatric patients with haemopathy or solid tumor, under antifungal prophylaxis with micafungin.
Key inclusion criteria (3 listed)
- Adult patient with haemopathy or paediatric patients with haemopathy or solid tumor.
- Patient hospitalized in haematology, onco-haematology or onco-paediatrics unit.
- Patient initiating antifungal prophylaxis with micafungin.
Key exclusion criteria (2 listed)
- Patient presenting documented fungal infection.
- Patient already included in a biomedical study impacting the care management of invasive fungal infection at the time of inclusion.
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 |
|---|---|---|
| MicafunginAlso: FK463, Mycamineintravenous | Drug | Micafungin |
Primary outcome
Breakthrough incidence of Invasive Fungal Infection (IFI), defined according to the revised EORTC/MSG criteria, during prophylaxis use of micafungin
Time frame: Up to 3 months
EORTC/MSG : European Organization for Research and Treatment of Cancer/ Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group
6 secondary outcomes
Odds ratio and 95% CI for each identified risk factors
Time frame: Up to 3 months
Incidence of IFI, defined according to the revised EORTC/MSG criteria
Time frame: Up to 3 months
Characteristics of patients treated with micafungin
Time frame: Day 0 (start of prophylaxis)
Conditions of use of micafungin
Time frame: Up to 3 months
Description of adverse events (AE) and serious adverse events (SAE)
Time frame: Up to 3 months
Characteristics of units
Time frame: Day 0
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 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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 and Scientific Affairs Manager, Infectious Diseases study director
Astellas Pharma S.A.S.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antifungal Prophylaxis and Haemopathy, run by Astellas Pharma S.A.S. at 17 sites in France.
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 3 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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.
What does the primary outcome measure?
Breakthrough incidence of Invasive Fungal Infection (IFI), defined according to the revised EORTC/MSG criteria, during prophylaxis use of micafungin (time frame: Up to 3 months). 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 21 Oct 2024.