Meropenem Dosage Strategy Based on PPK Model

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects:lower respiratory tract infection patients Study design:randomized control study.The patients in study group will accept meropenem therapy with the regimen decided by a software developed from a PPK-PD model. The patients in control group will accept meropenem therapy with the regimen decided by attending physician. Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency of meropenem therapy will be evaluated one week later from stop of meropenem therapy. Second endpoint: amount of used antibiotics and bacteriological successful rate.

Official Title
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Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients

Conditions
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Lower Respiratory Tract Infection

Intervention / Treatment
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* Drug: Routine meropenem therapy
* Drug: Meropenem therapy based on a PPK and PD model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sixty years and older patients hospitalized at the Peking University Third Hospital with community-acquired or hospital-acquired lower respiratory tract infection. Bacilli was idolated from lower respiratory tract specimens within 48 hours prior to study enrollment. The pathogen was sensitive to meropenem. Received broad-spectrum antibiotic therapy less than 24 hours, or no improvement after antibiotic therapy and pathogen was resistant to the used antibiotics. Exclusion Criteria: Had documented hypersensitivity to carbapenems. More than one pathogenic Gram-negative bacillus was isolated lower respiratory tract specimens. Positive HIV antibody titre. Had known or suspected tuberculosis or other infections caused by Gram-positive cocci, viruses or fungi at baseline.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>The participants in control group will accept routine meropenem therapy | Drug: Routine meropenem therapy<br>* Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician<br>* Other names: Standard care;|
| Experimental: Study group<br>The participants in study group will accept meropenem therapy based on a PPK and PD model. | Drug: Meropenem therapy based on a PPK and PD model<br>* Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model<br>* Other names: Experimental meropenem therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection; Meropenem; Pharmacokinetics; Pharmacodynamics