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NCT05665478
Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients
Conditions: Febrile Neutropenia, Pharmacokinetics, Pharmacodynamic, Carbapenems
Sex: All
Ages: 18 Years – 100 Years
Phase: NA
Enrollment: 100
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
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;The visualization software of meropenem individualized medication was developed with the help of JAVA development language, J2EE framework and SQL Server database.
Eligibility Criteria
Inclusion Criteria: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.Exclusion Criteria: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;Cases considered by the researcher as unsuitable for inclusion.
Source: ClinicalTrials.gov (NCT05665478). StuddyBuddy aggregates publicly available trial information.