Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Dec 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well a specific antibiotic called meropenem works for patients who have a serious condition known as febrile neutropenia, which is often seen in people with certain types of cancer. The researchers want to find the best way to give this medication to ensure it is both effective and safe. They will compare a new dosing method, predicted by a special model, to the standard treatment that is currently in use. Additionally, they have created a computer program to help personalize the dosing of meropenem for each patient based on their individual needs.

To participate in this trial, individuals must be at least 18 years old and have a malignant hematological disease (like leukemia) along with a fever and low white blood cell counts, which makes them more vulnerable to infections. They also need to have a specific infection that is sensitive to meropenem and have already reached a steady level of the drug in their blood. Participants will provide blood samples during the study, and they will be closely monitored for their response to the treatment. It’s important to note that certain people, such as those with allergies to meropenem or other serious health issues, will not be eligible to join. If you're considering participating, you'll need to sign a consent form to confirm your willingness to take part in this important research.

Gender

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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.