TABLE 1.
Characteristic | Aspergillus | Candida | Othera | Total |
---|---|---|---|---|
Patients dosed (%) | 33 (25) | 67 (50) | 33 (25) | 133 |
Male/female ratio | 20/13 | 40/27 | 26/7 | 86/47 |
Age (yr) [median (range)] | 45 (6–77) | 46 (1–84) | 46 (16–86) | 46 (1–86) |
Underlying disease or condition | ||||
Hematologic malignancy | 15 | 12 | 12 | 39 (29.3%) |
Solid tumor | 1 | 10 | 0 | 11 (8.3%) |
Bone marrow transplant | 9 | 24 | 12 | 45 (33.8%) |
Solid organ transplant | 4 | 4 | 1 | 9 (6.8%) |
Otherb | 4 | 17 | 8 | 29 (21.8%) |
Site of infection | ||||
Lung | 26 | 9 | 14 | 49 (36.8%) |
Skin | 2 | 0 | 2 | 4 (3.0%) |
Blood and/or disseminated | 0 | 30 | 2 | 32 (24.1%) |
Sinus | 1 | 0 | 2 | 3 (2.3%) |
Otherc | 4 | 28 | 14 | 46 (34.6%) |
Enrollment reason | ||||
Amphotericin B toxicity | 20 | 27 | 21 | 68 (51.1%) |
Renal insufficiency | 8 | 30 | 8 | 46 (34.6%) |
Otherd | 5 | 10 | 4 | 19 (14.3%) |
Baseline laboratory measurement | ||||
ANCe (1,000/mm3) [mean (range)] | 6.49 (0–31.1) | 9.00 (0–38.8) | 9.75 (0–160) | 8.56 (0–160) |
Serum creatinine (mg/dl) [mean (range)] | 2.28 (0.6–4.9) | 2.58 (0.8–7.2) | 2.63 (1.1–6.7) | 2.52 (0.6–7.2) |
Total bilirubin (mg/dl) [mean (range)] | 2.84 (0.4–22.0) | 4.45 (0.2–43.0) | 4.56 (0.3–33.8) | 4.09 (0.3–33.8) |
Histoplasma/Coccidioides, Cryptococcus, other molds, and other yeasts.
Other underlying diseases or conditions included human immunodeficiency virus infection, AIDS, chronic obstructive pulmonary disease, surgery, coagulopathy, diabetes mellitus, chronic granulomatous disease, sarcoid tumor, Crohn’s disease, anemia, hypertension, immunosuppression, prosthesis, thrombocytopenia, or none.
Other sites of infection included bone, brain, chest wall, central nervous system, esophagus, gastrointestinal culture, Hickman catheter, hip joint fluid, liver, oropharynx, peritoneum, spleen, and urinary tract; also, one patient had >1 site of infection.
Patients did not meet entry criteria but were considered to be at risk of nephrotoxicity.
ANC, absolute neutrophil count.