The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock
1 other identifier
observational
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2018
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedDecember 8, 2022
November 1, 2022
3.3 years
November 18, 2018
November 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cmax/MIC
PK/PD of Deoxycholic Acid Amphotericin B
14 days
Secondary Outcomes (1)
AUC24h/MIC
14 days
Study Arms (2)
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.
Interventions
Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d.
Eligibility Criteria
Patients with Sepsis admitted to ICU of Zhongda hospital
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
Zhongda Hospital
Nanjing, Jiangsu, 210009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huang Yingzi, PHD
Zhongda Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 18, 2018
First Posted
December 8, 2022
Study Start
February 28, 2019
Primary Completion
June 28, 2022
Study Completion
June 28, 2022
Last Updated
December 8, 2022
Record last verified: 2022-11