Febrile NeutropeniaNCT05665478
Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients
A study testing Dose prediction using population pharmacokinetic models in people with Febrile Neutropenia and Pharmacokinetics, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Febrile Neutropenia, Pharmacokinetics, Pharmacodynamic
- What is being tested?
- Dose prediction using population pharmacokinetic models
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- 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.
- Conditions
- Febrile Neutropenia, Pharmacokinetics, Pharmacodynamic, Carbapenems
- Being tested
- Dose prediction using population pharmacokinetic models
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose prediction using population pharmacokinetic modelsOther
Dose prediction using population pharmacokinetic models.
| Study group | Role | What they receive |
|---|---|---|
| model intervention group | Active comparator | The model was used for prediction to guide the later dosing regimen Receives: Other: Dose prediction using population pharmacokinetic models |
| Non-intervention group | No intervention | In the non-intervention group, the doctor chose the treatment plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start31 Dec 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yudong Qiu, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665478
- Sponsor's protocol ID
- 2022-LCYJ-PY-48
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05665478
- Acronym / sponsor ID
- 2022-LCYJ-PY-48
- Conditions
- Febrile Neutropenia, Pharmacokinetics, Pharmacodynamic, Carbapenems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| model intervention group | Active comparator | Other: Dose prediction using population pharmacokinetic modelsThe model was used for prediction to guide the later dosing regimen |
| Non-intervention group | No intervention | –In the non-intervention group, the doctor chose the treatment plan. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose prediction using population pharmacokinetic modelsDose prediction using population pharmacokinetic models. | Other | model intervention group |
Primary outcome
Change of antipyretic time 12 days after drug administration
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yudong Qiu study director
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Dose prediction using population pharmacokinetic models in people with Febrile Neutropenia and Pharmacokinetics, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mengying Liu (025-83106666, nobodyxyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of antipyretic time 12 days after drug administration (time frame: 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,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.