Empirical versus pre-emptive antifungal therapy of patients withhaematological malignanciesEmpirical versus pre-emptive (diagnosticdriven)antifungal therapy of patients treated for haematological malignancies or receiving an allogeneic stem cell transplant. A therapeutic open label phase IIIstrategy study of the EORTC Infectious Diseases and Leukemia Groups.

Phase 1

• Conditions: Invasive fungal infection in patients with hematological malignancies.; MedDRA version: 14.1Level: LLTClassification code 10017544Term: FungemiaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020814-27-NL
• Lead Sponsor: EORTC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-22
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

- Age 18 years or older.
- Start within 3 days before randomization, remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months OR start within 3 days before randomization, myeloablative conditioning regimen to prepare for an allogeneic HSCT. Permissible conditioning regimens are outlined in Appendix E.
- Planned hospital admission for the duration of the neutropenic phase (ANC< 0.5 x 109 /L).
- Planned oral or intravenous (I.V.) fluconazole for Candida prophylaxis at the dose of 400 mg/day; no other antifungal systemic prophylaxis is allowed.
- Patients with childbearing potential must have a negative serum pregnancy test and use effective contraceptive methods during the treatment period and for at least 3 months after the last study treatment.
- Female subjects who are lactating should discontinue nursing prior to the first dose.
- Adequate contraception in men.
- Patients of childbearing/ reproductive potential should use adequate birth control measures as defined by the investigator. By adequate birth control measures should be understood highly effective methods as defined by the Note 3 of the note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95):A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
such as implants, injectables, combined oral contraceptives, some IDUs, sexual abstinence or
vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on contraceptives should be addressed.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
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 556
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Previous or current history of proven or probable IFD.
- Current clinical diagnosis of pneumonia.
- Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol.
- History of allergy or any adverse reaction to echinocandin drugs (caspofungin, micafungin, or anidulafungin).
- Inadequately treated infection at study entry.
- Documented HIV infection.
- Concomitant inclusion on other clinical trial using an investigational drug for infectious disease.

Study & Design

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