Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

Dose Optimization of Carbapenem Antibacterials in Febrile Neutropenia Patients Based on PPK/PD Model and MAPB Method and Research on Individualized Drug Use Software

1. 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;
2. The visualization software of meropenem individualized medication was developed with the help of JAVA development language, J2EE framework and SQL Server database.

Study Overview

• Status: Not yet recruiting
• Conditions: Febrile Neutropenia; Pharmacokinetics; Pharmacodynamic; Carbapenems
• Intervention / Treatment: Other: Dose prediction using population pharmacokinetic models

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengying Liu; Phone Number: 025-83106666; Email: nobodyxyy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years old, regardless of gender;
2. 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);
3. 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;
4. The blood concentration of meropenem has reached a steady state;
5. Each patient's blood sample points ≥2, and cases with only one blood sample point can also be included in the database;
6. Sign the informed consent form.

Exclusion Criteria:

1. Patients with non-malignant hematological diseases;
2. Non-granular deficiency with fever;
3. Those who did not reach steady state when receiving meropenem;
4. There is a history of meropenem drug allergy;
5. The patient lacks treatment compliance based on the patient's history and the judgment of the researcher;
6. The patient has hemophagocytic syndrome;
7. Patients undergoing renal replacement therapy;
8. Patients with incomplete clinical evaluation data (such as lack of information on renal function and biochemical indicators, and inability to obtain blood samples);
9. The sample contains components that interfere with the determination of drug concentration (such as valproic acid and chloramphenicol);
10. Pregnant and lactating women;
11. Cases considered by the researcher as unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: model intervention group; The model was used for prediction to guide the later dosing regimen	Other: Dose prediction using population pharmacokinetic models; Dose prediction using population pharmacokinetic models.
No Intervention: Non-intervention group; In the non-intervention group, the doctor chose the treatment plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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,

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Study Director: Yudong Qiu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Neutropenia; Hyperthermia; Fever; Febrile Neutropenia
• Other Study ID Numbers: 2022-LCYJ-PY-48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No