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This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined.
This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration. The primary endpoint was the incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posaconazole tablet | Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole tablet | Drug | Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration. |
| Measure | Description | Time Frame |
|---|---|---|
| primary endpoint | 1. The incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection | From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis |
| Measure | Description | Time Frame |
|---|---|---|
| 2 | Posaconazole plasma concentration | Day 5 after posaconazole administration, and Days 1, 3, and 7 after the onset of gastrointestinal GVHD |
| 3 | Gastrointestinal GVHD grade, diarrhea status (frequency, volume), use and adjustment of immunosuppressants, neutrophil count |
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Inclusion Criteria:
Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation.
Patients who receive Posaconazole tablet as primary prophylaxis of invasive fungal disease.
Patients developing or developed acute gastrointestinal GVHD which require systemic immunosuppressive therapy of corticosteroids with- or-without other immunosuppressive agents including calcineurin inhibitors.
Gastrointestinal GVHD grades (I-IV) were recorded according to the Glucksberg criteria.
Patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aiming Pang, doctor | Hematopoietic stem cell transplantation Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | 300020 | China |
Data sharing is not considered for the time being due to patient privacy concerns.
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
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|
| From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis. |
| 4 | Adverse events | From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis. |