The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock

Southeast University, China

Status: Completed

Conditions: Fungal Infection

Treatments: Drug: Deoxycholic acid amphotericin B

Study type: Observational

Funder types: Other

Identifiers

NCT05642624

2018ZDSYLL066-P01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

sepsis group

Description:

invasive fungal infection patients who were diagnosed sepsis accoreding to the sepsis 3.0 guidlines.

Treatment:

Drug: Deoxycholic acid amphotericin B

septic shock group

Description:

invasive fungal infection patients who were diagnosed septic shock accoreding to the sepsis 3.0 guidlines.

Treatment:

Drug: Deoxycholic acid amphotericin B