Micafungin-Step therapy: Evaluating the rate of fungal infection diseases arising during antifungal therapy with micafungin followed by fluconazole versus fluconazole-monotherapy (or other azoles) in febrile patients

Phase 1

• Conditions: All patients who are suspicious of suffering from invasive fungal infections are included.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-003172-39-AT
• Lead Sponsor: Medizinische Universität Innsbruck, Abteilung für Hygiene und Medizinische Mikrobiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-22
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Suspicious of suffering from invasive fungal infections
• Female and male patients of > 18 years of age
• Patient receives appropriate antibiotic therapy
• Informed consent form signed by the patient or by the legal representative
• No treatment with antifungal agents 30 days prior to inclusion in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Known or expected hypersensitivity to active test substances or excipients
• Chronic liver disease by pathologic confirmation of cirrhosis, or Child-Pugh Stage B or C
• History or present signs of acute liver injury
• Previous enrollment to the present study
• Participation in another clinical trial with an investigational drug or investigational device during the last 30 days
• Received study drugs in the last 30 days prior to randomization.
• Positive pregnancy test
• Detection of Candida krusei or other Candida species resistant to fluconazole or micafungin
• Expected fatal or most likely unfavorable clinical outcome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to determine the rate of breakthrough fungal infections in a step down therapy consisting of micafungin followed by fluconazol comparted to fluconazole (or other azoles) monotherapy.;Secondary Objective: not applicable;Primary end point(s): The primary endpoint will be the determation of the rate of breakthrough fungal infections in a step down therapy consisting of micafungin followed by fluconazol comparted to fluconazole (or other azoles) monotherapy.;Timepoint(s) of evaluation of this end point: day 28 ± 2 after starting of antifungal therapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints will be the length of in hospital stay and the length of Intensive Care Unit stay, total days of antifungal treatment, fungal colonization index, changes from baseline values of the SOFA score (=sequential organ failure assessment), incidence of drug related unexpected serious adverse events and survival rate.;Timepoint(s) of evaluation of this end point: - days 7 ±1, 14±2 and 28±2 after start of antifungal treatment: Fungal Colonisation<br>- days -1-0, 1-5, 7 ±1, 14±2, 21±2 and 28±2: changes from baseline values of the sequential organ failure assessment score (determination of laboratory parameters are included)<br>- Daily screening for adverse drug effects + Screening 6 month after start of antifungal treatment<br>- days 7±1, 14±2, 28±2 and 6 month after start of therapy: Survival Rate<br>