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NCT05642624 Clinical Trial

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

Fungal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05642624
Other study ID # 2018ZDSYLL066-P01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 28, 2019
Est. completion date June 28, 2022

Study information
Verified date November 2022
Source Southeast University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 28, 2022
Est. primary completion date June 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Deoxycholic acid amphotericin B
Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d.

Locations
Country Name City State
China Zhongda Hospital Nanjing Jiangsu
China Zhongda Hospital, Southeast University Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax/MIC PK/PD of Deoxycholic Acid Amphotericin B 14 days
Secondary AUC24h/MIC Concentration of Deoxycholic Acid Amphotericin B 14 days
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