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:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT00020527
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Immunocompromised with one or more of the following conditions:
* Leukemia, lymphoma, or other cancer
* Underwent bone marrow or peripheral blood stem cell transplantation
* Aplastic anemia
* Planned chemotherapy likely to incur more than 10 days of neutropenia
* Absolute neutrophil count no greater than 500/mm\^3 AND at least 1 recorded fever over 38.0 ° C within 24 hours of study
* No proven invasive fungal infection at time of study entry
* Superficial fungal infection (e.g., cutaneous fungal infection, thrush, or candidal vaginitis) treatable with topical antifungals allowed
PATIENT CHARACTERISTICS:
Age:
* 2 to 17
Performance status:
* Not specified
Life expectancy:
* At least 5 days
Hematopoietic:
* See Disease Characteristics
* Hemodynamically stable with no hemodynamic compromise
Hepatic:
* AST or ALT no greater than 3 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 5 times ULN (unless related to bony metastases or other suspected bony processes)
* INR no greater than 1.6 (4.0 if receiving anticoagulants)
* No acute hepatitis or cirrhosis
Renal:
* Not specified
Other:
* Functioning central venous catheter in place
* No other condition or concurrent illness that would preclude study
* No prior allergy, hypersensitivity, or serious reaction to echinocandin antifungals
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception other than or in addition to oral contraceptives
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No prior enrollment into this study
* No more than 48 hours since prior parenteral systemic antibacterial therapy for fever and neutropenia
* At least 14 days since prior investigational antibiotic or antifungal drugs
* Concurrent topical antifungals (i.e., nystatin and/or azole formulations) for a superficial fungal infection allowed
* No other concurrent investigational drugs, including antibiotics or antifungals
* No concurrent rifampin, cyclosporine, phenytoin, carbamazapine, phenobarbital, or other antifungal treatments (except fluconazole)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT00020527
Study Brief:
Protocol Section:
NCT00020527