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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05642624
Enrollment
20
Registered
2022-12-08
Start date
2019-02-28
Completion date
2022-06-28
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal Infection

Keywords

Blood Concentration, Deoxycholic Acid Amphotericin B, Fungal Infection

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.

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.

Interventions

DRUGDeoxycholic acid amphotericin B

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

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cmax/MIC14 daysPK/PD of Deoxycholic Acid Amphotericin B

Secondary

MeasureTime frameDescription
AUC24h/MIC14 daysConcentration of Deoxycholic Acid Amphotericin B

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026