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To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | The participants in control group will accept routine meropenem therapy |
|
| Study group | Experimental | The participants in study group will accept meropenem therapy based on a PPK and PD model. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine meropenem therapy | Drug | Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate | The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy. Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy. Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy. | One week after antibiotic therapy finished. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Used Antibiotics | Record the amount of antibiotics usage during antibiotic therapy | participants will be followed for the duration of antibiotic therapy, an average of 10 days |
| Bacteriological Success Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingtao Zhou, M.D. | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospita | Haidian District | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28097633 | Derived | Zhou QT, He B, Shen N, Liang Y, Sun LN. Meropenem Dosing Based on a Population Pharmacokinetic-Pharmacodynamic Model in Elderly Patients with Infection of the Lower Respiratory Tract. Drugs Aging. 2017 Feb;34(2):115-121. doi: 10.1007/s40266-016-0431-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Meropenem therapy with regimen routinely decided by attending physician |
| FG001 | Study Group | Patients in Study group will accept meropenem therapy based on PPK and PD parameter. Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Meropenem therapy with regimen routinely decided by attending physician |
| BG001 | Study Group | Patients in Study group will accept meropenem therapy based on PPK and PD parameter. Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Success Rate | The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy. Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy. Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy. | Posted | Number | participants | One week after antibiotic therapy finished. |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | The participants in control group will accept routine meropenem therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | SNOMED CT | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Qingtao ZHOU | Peking University Third Hospital | 86-10-82265562 | zhouqingtaobysy@sina.com |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Meropenem therapy based on a PPK and PD model | Drug | Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model |
|
|
The bacterial success or failure will be evaluated at the end of meropenem therapy.
Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence.
| At the end of meropenem therapy, an average of 10 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The participants in stusy group will accept meropenem therapy based on a PPK and PD model. |
|
|
| Secondary | Amount of Used Antibiotics | Record the amount of antibiotics usage during antibiotic therapy | Posted | Median | Inter-Quartile Range | grams | participants will be followed for the duration of antibiotic therapy, an average of 10 days |
|
|
|
| Secondary | Bacteriological Success Rate | The bacterial success or failure will be evaluated at the end of meropenem therapy. Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence. | Posted | Number | participants | At the end of meropenem therapy, an average of 10 days. |
|
|
|
| 4 |
| 40 |
| 0 |
| 40 |
| EG001 | Study Group | The participants in study group will accept meropenem therapy based on a PPK and PD model. | 0 | 39 | 0 | 39 |
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