Invasive Fungal InfectionPhase 2MycaCOORDNCT01888458
Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)
A Phase 2 study testing Micafungin in people with Invasive Fungal Infection, run by Nantes University Hospital at 1 site in France.
Trial summary
Infections due to post transplant immune deficiency are a major problem following allogeneic stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood transplant (CB). Duration of neutropenia is one of the most important risk factor for invasive fungal infection (IFI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Invasive Fungal Infection
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Apr 2016
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells (cf conditioning regimen recommendation).
- Sex male or female
- Age between 18 and 65 years at the time of signing the informed consent form.
- Diagnosis of an hematologic disease for who a allograft decision has been taken
- not having a (HLA)-matched related or unrelated donor within two month after complete remission achievement
- Able to understand and voluntarily sign an informed consent form.
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- Subjects affiliated with an appropriate social security system
- Male, female without childbearing potential or negative urine pregnancy test at the screening visit prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures. Men must agree to use an acceptable method of contraception (for themselves or female partners) for the duration of the study
- Each subject will weigh 40 kg or more
Who cannot join
- Any suspected or documented invasive fungal infection at study entry or at any time prior to study entry
- Use of any systemic antifungal therapy within 72 hours prior to study entry
- Known history of allergy, hypersensitivity or intolerance to echinocandin agents
- Patient with any medical, psychological or social condition, which in the opinion of the investigator could increase the risk to the patient, or decrease the chance of obtaining satisfactory data to achieve the objectives of this study.
- Participation in a study testing a new drug or a new conditioning
- HIV, HBV or HCV positive
- Pregnant or breast feeding females.
- Subject protected by law.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation
Infections due to post transplant immune deficiency are a major problem following allogeneic stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood transplant (CB). Duration of neutropenia is one of the most important risk factor for invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative, phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few patients in this study received a CB transplant.
This is phase IIb, prospective, open-label, non-comparative study to assess the safety of micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB as source of stem cells.
- Conditions
- Invasive Fungal Infection
- Being tested
- Micafungin
- Keywords
- Adult, allo-Stem Cell Transplantation, Cord Blood
- 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
All patients meeting selection criteria will receive micafungin IV. Prophylaxis will start within 48 hours of the beginning of the transplant-related conditioning regimen until 5 days after recovery from neutropenia (ANC ≥ 500/µl), or occurrence of an IFI, or up to 42 days, or withdrawal for any reason (e.g. patient's or investigator's decision, development of intolerance, death), whichever come first
| Study group | Role | What they receive |
|---|---|---|
| Micafungine | Experimental | Not described Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety assessed by the incidence and type of adverse events (AE) occurring during the course of prophylaxis treatment, AE related to study drug, AE leading to study drug discontinuation, and evolution of vital signs and biological parameters.
Measured: 50 days
Secondary outcomes (3)
Incidence of Invasive Fungal Infection
Incidence of Invasive Fungal Infection (IFI) at the end of prophylaxis period and at the end of the 4-week follow-up period
Measured: 50 days
Incidence of fever of unknown origin
Incidence of fever of unknown origin requiring empirical antifungal treatment during prophylaxis period
Measured: 50 days
Survival rate
Survival rate and incidence of mortality related to IFI from the start of prophylaxis until the end of the 4-week follow-up period.
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauricette MICHALLET, PU PH, Principal investigator, Hospices Civils de LyonSabine FURST, PH, Principal investigator, Institut Paoli et Calmette (Marseille)Valérie COITEUX, PU PH, Principal investigator, CHRU de LilleStéphane VIGOUROUX, PH, Principal investigator, University Hospital, BordeauxMohamad MOHTY, PU PH, Principal investigator, AP-HP Saint AntoineThomas GASTINNE, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888458
- Sponsor's protocol ID
- RC13_0008
- Acronym
- MycaCOORD
- Status last verified
- May 2016
- First submitted
- 25 Jun 2013
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01888458
- Acronym / sponsor ID
- MycaCOORD / RC13_0008
- Conditions
- Invasive Fungal Infection
- Keywords
- Adult, allo-Stem Cell Transplantation, Cord Blood
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Jun 2013 (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.
Infections due to post transplant immune deficiency are a major problem following allogeneic stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood transplant (CB). Duration of neutropenia is one of the most important risk factor for invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative, phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few patients in this study received a CB transplant.
This is phase IIb, prospective, open-label, non-comparative study to assess the safety of micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB as source of stem cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micafungine | Experimental | Drug: Micafungin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells (cf conditioning regimen recommendation).
- Sex male or female
- Age between 18 and 65 years at the time of signing the informed consent form.
- Diagnosis of an hematologic disease for who a allograft decision has been taken
- not having a (HLA)-matched related or unrelated donor within two month after complete remission achievement
Key exclusion criteria (8 listed)
- Any suspected or documented invasive fungal infection at study entry or at any time prior to study entry
- Use of any systemic antifungal therapy within 72 hours prior to study entry
- Known history of allergy, hypersensitivity or intolerance to echinocandin agents
- Patient with any medical, psychological or social condition, which in the opinion of the investigator could increase the risk to the patient, or decrease the chance of obtaining satisfactory data to achieve the objectives of this study.
- Participation in a study testing a new drug or a new conditioning
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 |
|---|---|---|
| MicafunginAll patients meeting selection criteria will receive micafungin IV. Prophylaxis will start within 48 hours of the beginning of the transplant-related conditioning regimen until 5 days after recovery from neutropenia (ANC ≥ 500/µl), or occurrence of an IFI, or up to 42 days, or withdrawal for any reason (e.g. patient's or investigator's decision, development of intolerance, death), whichever come first | Drug | Micafungine |
Primary outcome
Safety
Time frame: 50 days
Safety assessed by the incidence and type of adverse events (AE) occurring during the course of prophylaxis treatment, AE related to study drug, AE leading to study drug discontinuation, and evolution of vital signs and biological parameters.
3 secondary outcomes
Incidence of Invasive Fungal Infection
Time frame: 50 days
Incidence of fever of unknown origin
Time frame: 50 days
Survival rate
Time frame: 50 days
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 20 May 2016.
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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.
Mauricette MICHALLET, PU PH principal investigator
Hospices Civils de Lyon
Sabine FURST, PH principal investigator
Institut Paoli et Calmette (Marseille)
Valérie COITEUX, PU PH principal investigator
CHRU de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micafungin in people with Invasive Fungal Infection, run by Nantes University Hospital at 1 site 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 9 inclusion and 8 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 20 May 2016. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety (time frame: 50 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 20 May 2016.