Exposure to micafungin given twice/week compared to once/day.

Phase 1

• Conditions: prophylaxis for patients at high risk for invasive fungal diseases; MedDRA version: 17.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002848-93-BE
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-01
• Study Completion: 2016-05-30
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patient receives immunosuppressive therapy for acuteGvHD grade II-IV or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
2.Subject is at least 18 of age on the day of providing informed consent.
3.Has no signs or symptoms of invasive fungal disease
4.If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
5.Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD.
6.Is managed with a central venous catheter (preferably a quadruple Ar-row-Howes™ Quad-Lumen 8.5,5 French; Arrow International).
7.Subject is able and willing to sign the Informed Consent before screening evaluations.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation.
2.History of or current abuse of drugs, alcohol or solvents.
3.Inability to understand the nature of the trial and the procedures re-quired.
4.Has not previously participated in this trial.

Study & Design

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