Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

Study Overview
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Brief Summary
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The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data

Detailed Description
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This study is a prospective, randomized controlled trial, which the subjects were severe sepstic patients for selecting Meropenem as antimicrobial drugs. The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data, eventually demonstrate the effecacy and safety of Meropenem in patients with severe infection and optimize the best clinical practice for antimicrobial agents.

Official Title
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Efficacy and Pharmacokinetics of Meropenem in Different Administration for Patients With Severe Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Meropenem Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients, whose informed consent has been obtained; Clinical diagnosis of Sepsis Exclusion Criteria: Pregnancy or lactation; Treated with other carbapenems; Cannot be evaluated for efficacy and safety result from lack of clinical and laboratory parameter for Infection assessment; Allergy to meropenem or other β-lactams, or the history of allergy; Resistant to meropenem according to the antimicrobial susceptibility test; Epilepsy or history of epilepsy; History of seizures; Combined medicine with sodium valproate; Combined medicine with anti-MRSA, anti-fungal drugs; with severe liver or renal dysfunction; Terminal cancer; Septic shock; APACH II ≥20; Inappropriate to participate in the trial evaluated by investigator.

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h | Drug: Meropenem Injection<br>* Different administration types between two groups<br>* Other names: meropenem,MEPEM;|
| Other: Control group<br>meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h | Drug: Meropenem Injection<br>* Different administration types between two groups<br>* Other names: meropenem,MEPEM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T>MIC | Time above MIC% per administration interval | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APACHE II score | Change of Acute physiology and chronic health evaluation score (APACHE II score) during period of treatment | Day 0,Day 4,Day 8 | 
| SOFA | Change of Sepsis-related Organ Failure Assessment score (sofa) during period of treatment | Day 0,Day 4,Day 8 | 
| Mortality | Mortality within 28 days | Day 28 | 
| highest temperature | Variation of the highest temperature | Day 0,Day 4,Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis，meropenem，2 steps administration