Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

Phase 4

Completed

• Conditions: Sepsis
• Interventions: Drug: Meropenem Injection

• Registration Number: NCT03645668
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-01-30
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Primary Completion: 2019-11-14
• Study Completion: 2019-12-14
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Meropenem Injection	meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h
Control group	Meropenem Injection	meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h

Primary Outcome Measures

Name	Time	Method
T>MIC	Day 1	Time above MIC% per administration interval

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China