Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

NCT ID: NCT05665478

Last Updated: 2022-12-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2025-12-31

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.

Conditions

Febrile Neutropenia; Pharmacokinetics; Pharmacodynamic; Carbapenems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

model intervention group

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

Group Type: ACTIVE_COMPARATOR

Dose prediction using population pharmacokinetic models

Intervention Type: OTHER

Dose prediction using population pharmacokinetic models.

Non-intervention group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dose prediction using population pharmacokinetic models

Dose prediction using population pharmacokinetic models.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yudong Qiu

Role: STUDY_DIRECTOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Central Contacts

Mengying Liu

Role: CONTACT

Phone: 025-83106666

Email: nobodyxyy@126.com

Other Identifiers

2022-LCYJ-PY-48

Identifier Type: -

Identifier Source: org_study_id