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Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

Primary Purpose

Febrile Neutropenia, Pharmacokinetics, Pharmacodynamic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dose prediction using population pharmacokinetic models
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Febrile Neutropenia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years old, regardless of gender; Patients with malignant hematological diseases with neutropenia and fever are judged as high-risk patients according to the Guidelines for Clinical Application of Antibiotics in Patients with Neutropenia and Fever in China (2020 Edition); There is infection, and the results of drug sensitivity test show that pathogenic bacteria are sensitive to meropenem or meropenem is used according to experience; The blood concentration of meropenem has reached a steady state; Each patient's blood sample points ≥2, and cases with only one blood sample point can also be included in the database; Sign the informed consent form. Exclusion Criteria: Patients with non-malignant hematological diseases; Non-granular deficiency with fever; Those who did not reach steady state when receiving meropenem; There is a history of meropenem drug allergy; The patient lacks treatment compliance based on the patient's history and the judgment of the researcher; The patient has hemophagocytic syndrome; Patients undergoing renal replacement therapy; Patients with incomplete clinical evaluation data (such as lack of information on renal function and biochemical indicators, and inability to obtain blood samples); The sample contains components that interfere with the determination of drug concentration (such as valproic acid and chloramphenicol); Pregnant and lactating women; Cases considered by the researcher as unsuitable for inclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    model intervention group

    Non-intervention group

    Arm Description

    The model was used for prediction to guide the later dosing regimen

    In the non-intervention group, the doctor chose the treatment plan.

    Outcomes

    Primary Outcome Measures

    Change of antipyretic time 12 days after drug administration
    The antipyretic time of the experimental group is compared with that of the control group. If the antipyretic time of the experimental group is shorter than that of the control group, the experimental treatment is considered effective.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2022
    Last Updated
    December 23, 2022
    Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05665478
    Brief Title
    Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients
    Official Title
    Dose Optimization of Carbapenem Antibacterials in Febrile Neutropenia Patients Based on PPK/PD Model and MAPB Method and Research on Individualized Drug Use Software
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 31, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Evaluating the differences in the efficacy and safety of meropenem optimal dosing regimen predicted by the PPK/PD model combined with MAPB method for patients with malignant hematological myelopathy accompanied by fever, as compared with the current conventional treatment regimen; The visualization software of meropenem individualized medication was developed with the help of JAVA development language, J2EE framework and SQL Server database.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Febrile Neutropenia, Pharmacokinetics, Pharmacodynamic, Carbapenems

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    model intervention group
    Arm Type
    Active Comparator
    Arm Description
    The model was used for prediction to guide the later dosing regimen
    Arm Title
    Non-intervention group
    Arm Type
    No Intervention
    Arm Description
    In the non-intervention group, the doctor chose the treatment plan.
    Intervention Type
    Other
    Intervention Name(s)
    Dose prediction using population pharmacokinetic models
    Intervention Description
    Dose prediction using population pharmacokinetic models.
    Primary Outcome Measure Information:
    Title
    Change of antipyretic time 12 days after drug administration
    Description
    The antipyretic time of the experimental group is compared with that of the control group. If the antipyretic time of the experimental group is shorter than that of the control group, the experimental treatment is considered effective.
    Time Frame
    Baseline and at the first 0 hour, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours, 240 hours, 264 hours, 288 hours after administration,

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years old, regardless of gender; Patients with malignant hematological diseases with neutropenia and fever are judged as high-risk patients according to the Guidelines for Clinical Application of Antibiotics in Patients with Neutropenia and Fever in China (2020 Edition); There is infection, and the results of drug sensitivity test show that pathogenic bacteria are sensitive to meropenem or meropenem is used according to experience; The blood concentration of meropenem has reached a steady state; Each patient's blood sample points ≥2, and cases with only one blood sample point can also be included in the database; Sign the informed consent form. Exclusion Criteria: Patients with non-malignant hematological diseases; Non-granular deficiency with fever; Those who did not reach steady state when receiving meropenem; There is a history of meropenem drug allergy; The patient lacks treatment compliance based on the patient's history and the judgment of the researcher; The patient has hemophagocytic syndrome; Patients undergoing renal replacement therapy; Patients with incomplete clinical evaluation data (such as lack of information on renal function and biochemical indicators, and inability to obtain blood samples); The sample contains components that interfere with the determination of drug concentration (such as valproic acid and chloramphenicol); Pregnant and lactating women; Cases considered by the researcher as unsuitable for inclusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mengying Liu
    Phone
    025-83106666
    Email
    nobodyxyy@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yudong Qiu
    Organizational Affiliation
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

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