Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

Nanjing University

Status: Not yet enrolling

Conditions: Febrile Neutropenia; Pharmacodynamic; Carbapenems; Pharmacokinetics

Treatments: Other: Dose prediction using population pharmacokinetic models

Study type: Interventional

Funder types: Other

Identifiers

NCT05665478

2022-LCYJ-PY-48

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

model intervention group

Active Comparator group

Description:

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

Treatment:

Other: Dose prediction using population pharmacokinetic models

Non-intervention group

No Intervention group

Description:

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