- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05642624
The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Zhongda Hospital, Southeast University
-
Nanjing, Jiangsu, China, 210009
- Zhongda Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
sepsis group
invasive fungal infection patients who were diagnosed sepsis accoreding to the sepsis 3.0 guidlines.
|
Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d.
Other Names:
|
septic shock group
invasive fungal infection patients who were diagnosed septic shock accoreding to the sepsis 3.0 guidlines.
|
Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax/MIC
Time Frame: 14 days
|
PK/PD of Deoxycholic Acid Amphotericin B
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC24h/MIC
Time Frame: 14 days
|
Concentration of Deoxycholic Acid Amphotericin B
|
14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Huang Yingzi, PHD, Zhongda Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections and Mycoses
- Infections
- Communicable Diseases
- Mycoses
- Invasive Fungal Infections
- Anti-Infective Agents
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Amebicides
- Cholagogues and Choleretics
- Deoxycholic Acid
- Amphotericin B
- Liposomal amphotericin B
Other Study ID Numbers
- 2018ZDSYLL066-P01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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