NCT Number: NCT07532850
The goal of this prospective study is to describe the pharmacokinetic characteristics of liposomal amphotericin B during plasma exchange therapy for severe invasive fungal infections in Chinese patients, preliminarily explore the influencing factors of in vivo exposure variability of liposomal amphotericin B, and integrate the findings with efficacy and safety outcomes.
The main questions it aims to answer is: Clarifying the correlation between the concentration, efficacy, and safety of different forms of liposomal amphotericin B in a special population, explore the changes in drug concentration mediated by plasma exchange, elucidate the mechanism of individual differences in efficacy and the optimal dosage, in order to provide a basis for personalized treatment of liposomal amphotericin B.
The study plans to collect pharmacokinetic samples from 10 adult (aged ≥ 18 years) severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
By systematically optimizing plasma sample pretreatment, chromatographic conditions, and mass spectrometry conditions, and conducting methodological investigations on specificity, minimum quantification limit, minimum detection limit, linear range, accuracy, precision, matrix effects, stability system, etc., an accurate, rapid, and highly sensitive UPLC-MS/MS method is established.
When the patient's dosage is stable, collect 4mL of intravenous blood from the EDTA-K2（Ethylenediaminetetraacetic acid dipotassium salt） collection tube within 1 hour before the administration of liposomal amphotericin B before plasma exchange, immediately after infusion, 1 hour, 6 hours, 12 hours after infusion, 5 minutes before and immediately after plasma exchange, immediately after the next infusion after plasma exchange, and 24 hours. Subsequent pharmacokinetic studies will be conducted.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age ≥ 18 years old, gender not limited; According to < The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision) >, the diagnosis is neutropenia with fever, possible, probable, and proven IFD invasive fungal disease;
Exclusion criteria
Confirmed patients with allergies/rapid onset severe allergic reactions/intolerance to AmB Subjects who are known to be insensitive or resistant to amphotericin B treatment, such as those with invasive Aspergillus terreus and Aspergillus nidulans
-
Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
Time frame: through study completion, an average of 2 years
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
Time frame: Through study completion, an average of 2 years
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
Time frame: Through study completion, an average of 2 years
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
Time frame: Through study completion, an average of 2 years
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
The area under the blood drug concentration time curve during the dosing cycle and up to infinity (AUC0- τ and AUC 0- ∞, respectively)
Time frame: Through study completion, an average of 2 years
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations:
Terminal elimination half-life (t1/2)
Contact information is provided by the study sponsor or research team.
Institute of Hematology & Blood Diseases Hospital, China
Other
Study on the Pharmacokinetic Characteristics, Safety, and Efficacy of Liposomal Amphotericin B in Critically Ill Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06754436
Bacterial Infections and Mycoses, Infections
Beijing, Beijing Municipality, China
View Trial DetailsNCT06220370
Bacterial Infections, Bacterial Infections and Mycoses
View Trial DetailsNCT07725263
Agranulocytosis, Anemia
Haikou, Hainan, China
View Trial DetailsNCT07716878
Bacterial Infections and Mycoses, Hematopoietic Stem Cell Transplantation (HSCT)
Guangzhou, Guangdong, China
View Trial Details