Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

NCT05665478 | Unknown

• 1 other identifier: 2022-LCYJ-PY-48
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (1)

• 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,

Study Arms (2)

model intervention group

ACTIVE COMPARATOR

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

Other: Dose prediction using population pharmacokinetic models

Non-intervention group

NO INTERVENTION

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

Interventions

Dose prediction using population pharmacokinetic models OTHER

Dose prediction using population pharmacokinetic models.

model intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Yudong Qiu

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

Central Study Contacts

Mengying Liu

CONTACT

025-83106666; nobodyxyy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: December 27, 2022
• Study Start: December 31, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 27, 2022

Record last verified: 2022-11