Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2019-12-14

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

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h

Group Type EXPERIMENTAL

Meropenem Injection

Intervention Type DRUG

Different administration types between two groups

Control group

meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h

Group Type OTHER

Meropenem Injection

Intervention Type DRUG

Different administration types between two groups

Interventions

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Meropenem Injection

Different administration types between two groups

Intervention Type DRUG

Other Intervention Names

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meropenem,MEPEM

Eligibility Criteria

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Inclusion Criteria

1. Inpatients, whose informed consent has been obtained;
2. Clinical diagnosis of Sepsis

Exclusion Criteria

1. Pregnancy or lactation;
2. Treated with other carbapenems;
3. Cannot be evaluated for efficacy and safety result from lack of clinical and laboratory parameter for Infection assessment;
4. Allergy to meropenem or other β-lactams, or the history of allergy;
5. Resistant to meropenem according to the antimicrobial susceptibility test;
6. Epilepsy or history of epilepsy;
7. History of seizures;
8. Combined medicine with sodium valproate;
9. Combined medicine with anti-MRSA, anti-fungal drugs;
10. with severe liver or renal dysfunction;
11. Terminal cancer;
12. Septic shock;
13. APACH II ≥20;
14. Inappropriate to participate in the trial evaluated by investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No