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

Sponsor

Southeast University, China (Other)

Overall Status

Completed

CT.gov ID

NCT05642624

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fungal Infection	Drug: Deoxycholic acid amphotericin B

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 28, 2019

Actual Primary Completion Date :

Jun 28, 2022

Actual Study Completion Date :

Jun 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
sepsis group invasive fungal infection patients who were diagnosed sepsis accoreding to the sepsis 3.0 guidlines.	Drug: Deoxycholic acid amphotericin B Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d. Other Names: amphotericin B
septic shock group invasive fungal infection patients who were diagnosed septic shock accoreding to the sepsis 3.0 guidlines.	Drug: Deoxycholic acid amphotericin B Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d. Other Names: amphotericin B

Arm

Intervention/Treatment

sepsis group

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

Drug: Deoxycholic acid amphotericin B

Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d.

Other Names:

amphotericin B

septic shock group

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

Drug: Deoxycholic acid amphotericin B

Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d.

Other Names:

amphotericin B

Outcome Measures

Primary Outcome Measures

Cmax/MIC [14 days]
PK/PD of Deoxycholic Acid Amphotericin B

Secondary Outcome Measures

AUC24h/MIC [14 days]
Concentration of Deoxycholic Acid Amphotericin B

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.