Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Sepsis

Treatments: Drug: Meropenem Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03645668

XH-18-003

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Drug: Meropenem Injection

Control group

Other group

Description:

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

Treatment:

Drug: Meropenem Injection