TABLE 5.
Subjects who experienced a breakthrough invasive fungal infection after removal from study drug that was caused by the same Candida species identified as a colonizer
| Prophylactic agent | IFI and colonizing species | Day of IFI onset/duration of prophylaxis (days)/time since last dose (days) | Results for isolates cultured from subjects with an invasive fungal infection |
|||
|---|---|---|---|---|---|---|
| Culture day/sourcea | MIC (μg/ml) |
|||||
| Posaconazole | Fluconazole | Itraconazole | ||||
| Posaconazole | C. glabrata | 75/33/42 | 59/mouth | 1 | 16 | 1 |
| 75/blood | NAb | NA | NA | |||
| C. glabrata | 165/138/27 | 35/mouth | 4 | 64 | 8 | |
| 60/mouth | 4 | >64 | 4 | |||
| 88/mouth | 2 | >64 | 2 | |||
| C. glabrata | 25/3/22 | 1/stool | 4 | 16 | 8 | |
| 3/stool | 0.5 | 8 | 1 | |||
| 23/stool | 0.125 | 4 | 0.125 | |||
| 25/blood | 0.5 | 8 | 2 | |||
| C. glabrata | 37/9/28 | 7/stool | 1 | 8 | 1 | |
| 9/urine | NA | NA | NA | |||
| 10/stool | 1 | 8 | 2 | |||
| 14/stool | NA | NA | NA | |||
| 37/blood | NA | NA | NA | |||
| C. tropicalis | 45/24/21 | −3/stool | <0.015 | 0.25 | 0.03 | |
| −3/pharynx | <0.015 | 0.5 | 0.03 | |||
| 2/stool | <0.015 | 0.25 | <0.015 | |||
| 2/pharynx | <0.015 | 0.25 | 0.03 | |||
| 9/stool | <0.015 | 0.5 | 0.03 | |||
| 45/blood | NA | NA | NA | |||
| Fluconazole | C. glabrata | 31/28/3 | 16/mouth | <0.5 | <2 | <1 |
| 31/mouth | <0.5 | <4 | <1 | |||
| C. glabrata | 143/116/27c | 1/mouth | 0.5 | 16 | 1 | |
| 12/mouth | 2 | 64 | 4 | |||
| 62/mouth | 4 | 64 | 8 | |||
| 85/mouth | 4 | 64 | 8 | |||
| 111/mouth | 4 | 64 | >8 | |||
| 143/blood | NA | NA | NA | |||
| C. glabrata | 168/113/55 | −2/mouth | 1 | 64 | 1 | |
| 15/mouth | 2 | 64 | 4 | |||
| 43/mouth | 2 | 64 | 2 | |||
| 176/mouth | 4 | >64 | 2 | |||
| C. glabrata | 172/114/58d | −2/mouth | 0.5 | 16 | 1 | |
| 56/mouth | 0.25 | 4 | 0.5 | |||
| 86/mouth | 1 | 16 | 2 | |||
| 114/mouth | 2 | 32 | 8 | |||
| 172/blood | NA | NA | NA | |||
| 177/mouth | 1 | 32 | 1 | |||
| C. krusei | 19/6/13 | 1/pharynx | 0.06 | 32 | 0.125 | |
| 6/stool | 0.125 | 64 | 0.5 | |||
| 6/pharynx | 0.06 | 32 | 0.5 | |||
| 16/stool | 0.25 | 64 | 0.25 | |||
| 16/pharynx | 0.25 | 64 | 0.5 | |||
| 19/blood | 0.06 | 32 | 0.25 | |||
Cultures of samples from the from mouth (study 1, HSCT recipients) and from the stool and pharynx (study 2, subjects with AML or MDS) were part of a surveillance program; blood and urine cultures were performed in cases with an IFI.
NA, not available.
Subject 002.
Subject 497.