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To explore the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis/septic shock;To compare the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis and septic shock.
This was a single-center study.Patients who were diagnosed with in invasive fungal infection receieved deoxycholic acid amphotericin B during the study period.The information was recored including the general condition, infection index, PK/PD index and drug-related side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sepsis group | invasive fungal infection patients who were diagnosed sepsis accoreding to the sepsis 3.0 guidlines. |
| |
| septic shock group | invasive fungal infection patients who were diagnosed septic shock accoreding to the sepsis 3.0 guidlines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deoxycholic acid amphotericin B | Drug | Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax/MIC | PK/PD of Deoxycholic Acid Amphotericin B | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC24h/MIC | Concentration of Deoxycholic Acid Amphotericin B | 14 days |
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Inclusion Criteria:
Patients age more than 18 years old; Meet the criteria of Sepsis 3.0; Admitted to ICU; Patients were suspected or diagnosis of IFI,doctors determined the use of deoxycholic acid amphotericin B.
Exclusion Criteria:
Serum creatinine≥221umol/L; Deoxycholic acid amphotericin B or amphotericin B liposome were used for the past 7 days; Patients being treated with rifampicin; Unable to tolerate treatment of deoxycholic acid amphotericin B; BMI<18.5 or >30; Tumors; Pregnancy; Estimated time of survival<24h; Patients who participated in other studies within 30 days.
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Patients with Sepsis admitted to ICU of Zhongda hospital
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| Name | Affiliation | Role |
|---|---|---|
| Huang Yingzi, PHD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Southeast University | Nanjing | Jiangsu | 210009 | China | ||
| Zhongda Hospital |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Nanjing |
| Jiangsu |
| 210009 |
| China |