Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02172768
Eligibility Criteria:
Inclusion Criteria:
* Patient receives immunosuppressive therapy for acute GvHD grade II-IV or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
* Subject is at least 18 of age on the day of providing informed consent.
* Has no signs or symptoms of invasive fungal disease
* If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
* Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD.
* Is managed with a central venous catheter (preferably a quadruple Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International).
* Subject is able and willing to sign the Informed Consent before screening evaluations.
Exclusion Criteria:
* Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature of the trial and the procedures required.
* Has not previously participated in this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02172768
Study Brief:
Protocol Section:
NCT02172768