A PHASE II, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MICAFUNGIN SALVAGE MONO THERAPY VERSUS ACTIVE CONTROL INTRAVENOUS SALVAGE MONO THERAPY IN PATIENTS WITH INVASIVE ASPERGILLOSIS - Micafungin Salvage Mono Therapy in Invasive Aspergillosis

• Conditions: Patients with haematopoietic stem cell transplantation (HSCT), acute leukaemia, myelodysplastic syndrome (MDS) and with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and who are also refractory or intolerant to previous systemic antifungal therapy. Criteria for refractoriness and intolerance are defined in Appendix III of the study protocol.; MedDRA version: 8.1Level: LLTClassification code 10022881Term: Invasive bronchopulmonary aspergillosis

• Registration Number: EUCTR2005-004988-27-DE
• Lead Sponsor: Astellas Pharma BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. A patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person. A patient who is unconscious where written informed consent is given by a legal representative in accordance with national regulations and after approval was obtained from the relevant Independent Ethics Committee
2. Patient with allogeneic or autologous haematopoietic stem cell transplantation (HSCT), acute leukaemia or myelodysplastic syndrome (MDS)
3. Patient is 18 years of age or older
4. Patient with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis at baseline as defined in Appendix II
5. Patient is either
a) refractory to at least 7 consecutive days of a systemic antifungal agent (amphotericin B products or voriconazole) used as first line therapy
or
b) intolerant to at least one dose of a systemic antifungal agent (amphotericin B products or voriconazole)
prior to study drug administration as defined in Appendix III
6. Female patient of child bearing potential must have a negative pregnancy test prior to enrolment and must agree to practice effective birth control during 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

1. Patient with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, or with sinus aspergillosis or external otitis without any evidence of Aspergillus tissue invasion
2. Patient with invasive fungal infection other than invasive aspergillosis
3. Patient has been previously enrolled in this study
4. Patient is pregnant or breast-feeding mother
5. Patient is unlikely to comply with the visits scheduled in the protocol
6. Patient is participating, or has participated, in another investigational drug trial or is receiving, or has received, an investigational drug within the last 28 days before entry into this study except for investigational drugs against cancer (e.g. leukaemia)
7. Patient with less than 7 days life expectancy
8. Patient had a previous salvage therapy for the current episode of Aspergillus infection
9. Patient with first line monotherapy of itraconazole solely for the current episode of Aspergillus infection
10. Patient with first line therapy of caspofungin used for the current episode of invasive aspergillosis
11. Patient with known hypersensitivity or intolerance to echinocandins or to any of the excipients.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: •To evaluate the efficacy and safety of micafungin in patients with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and who are also refractory or intolerant to previous systemic antifungal therapy.<br>•To compare the efficacy and safety of the micafungin therapy arm with the active control arm.<br>;Secondary Objective: ;Primary end point(s): The primary endpoint is the IDRB assessment of overall success at EoT defined as complete or partial clinical response according to Appendix IV. The assessment of clinical response will be based on clinical signs and symptoms and radiological findings. The IDRB will be treatment blinded.