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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT00008359
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Leukemia, lymphoma, or other cancer that has been previously treated with chemotherapy or bone marrow or peripheral blood stem cell transplantation
* Absolute neutrophil count less than 500/mm\^3 for past 96 hours and not expected to recover in next 48 hours
* Received at least 96 hours of parenteral systemic antibacterial therapy
* Fever greater than 38.0 degrees Celsius
* Adequately managed bacterial infection allowed if all of the following are true:
* Negative blood cultures
* Received at least 5 days of antibiotics to which any bacterial isolates are sensitive
* Surgical drainage of any abscess fluid or surgical debridement of infected tissues
* Removal of infected catheters
* No invasive fungal infection
* Not previously enrolled on this study
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* Karnofsky 30-100%
Life expectancy:
* At least 5 days
Hematopoietic:
* Platelet count at least 5,000/mm\^3
* INR no greater than 1.6 (no greater than 4.0 if receiving anticoagulants)
Hepatic:
* Bilirubin no greater than 3 times upper limit of normal (ULN)
* AST or ALT no greater than 5 times ULN
* Alkaline phosphatase no greater than 3 times ULN
* No acute hepatitis or cirrhosis
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No allergy, hypersensitivity, or prior serious reaction to any echinocandin antifungal or amphotericin B formulation
* No other condition or illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* No concurrent investigational antineoplastic therapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* At least 10 days since prior parenteral amphotericin B
* At least 14 days since prior investigational antibiotic, antifungal, or immunosuppressive drug
* No concurrent rifampin or cyclosporine
* No other concurrent investigational antibiotic, antifungal, or immunosuppressive drug
* No concurrent alcohol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00008359
Study Brief:
Protocol Section:
NCT00008359