Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

Not Applicable

Not yet recruiting

• Conditions: Pharmacodynamic; Febrile Neutropenia; Pharmacokinetics; Carbapenems
• Interventions: Other: Dose prediction using population pharmacokinetic models

• Registration Number: NCT05665478
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Study Start: 2022-12-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
model intervention group	Dose prediction using population pharmacokinetic models	The model was used for prediction to guide the later dosing regimen

Primary Outcome Measures

Name	Time	Method
Change of antipyretic time 12 days after drug administration	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,	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.