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Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05665478
Collaborator
(none)
100
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dose prediction using population pharmacokinetic models
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dose Optimization of Carbapenem Antibacterials in Febrile Neutropenia Patients Based on PPK/PD Model and MAPB Method and Research on Individualized Drug Use Software
Anticipated Study Start Date :
Dec 31, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: model intervention group

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

Other: Dose prediction using population pharmacokinetic models
Dose prediction using population pharmacokinetic models.
No Intervention: Non-intervention group

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

Outcome Measures

Primary Outcome Measures

  1. Change of antipyretic time 12 days after drug administration [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,]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Study Director: Yudong Qiu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT05665478
Other Study ID Numbers:
  • 2022-LCYJ-PY-48
First Posted:
Dec 27, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neutropenia
Febrile Neutropenia
Hyperthermia
Fever

Study Results

No Results Posted as of Dec 27, 2022