NCT02127788

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 3, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2016

Completed
Last Updated

October 21, 2024

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

April 17, 2014

Last Update Submit

October 18, 2024

Conditions

Antifungal ProphylaxisHaemopathy

Keywords

HaematologyMicafunginObservational studyProphylaxisInvasive Fungal InfectionFrance

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 3 months

Secondary Outcomes (6)

  • Odds ratio and 95% CI for each identified risk factors

    Up to 3 months

  • Incidence of IFI, defined according to the revised EORTC/MSG criteria

    Up to 3 months

  • Characteristics of patients treated with micafungin

    Day 0 (start of prophylaxis)

  • Conditions of use of micafungin

    Up to 3 months

  • Description of adverse events (AE) and serious adverse events (SAE)

    Up to 3 months

  • +1 more secondary outcomes

Study Arms (1)

Micafungin

Patients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin.

Drug: Micafungin

Interventions

MicafunginDRUG

intravenous

Also known as: FK463, Mycamine
Micafungin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized, adult patients with haemopathy or paediatric patients with haemopathy or solid tumor, under antifungal prophylaxis with micafungin.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient presenting documented fungal infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Site

Angers, 44933, France

Location

Site

Angers, 49933, France

Location

Site

Béziers, 34525, France

Location

Site

Bordeaux, 33076, France

Location

Site

Brest, 29609, France

Location

Site

Clermont-Ferrand, 63003, France

Location

Site

Lille, 59037, France

Location

Site

Limoges, 37042, France

Location

Site

Marseille, 13273, France

Location

Site

Marseille, 13385, France

Location

Site

Metz, 57038, France

Location

Site

Montpellier, 34295, France

Location

Site

Nantes, 44093, France

Location

Site

Paris, 75012, France

Location

Site

Paris, 75019, France

Location

Site

Saint-Denis La Réunion, 97400, France

Location

Site

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Micafungin

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Medical and Scientific Affairs Manager, Infectious Diseases

    Astellas Pharma S.A.S.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

May 1, 2014

Study Start

July 3, 2014

Primary Completion

January 27, 2016

Study Completion

January 27, 2016

Last Updated

October 21, 2024

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

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/.

Locations

FR(17)