Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

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

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

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Drug: Meropenem Injection

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Shanghai Xinhua hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h	Drug: Meropenem Injection; Different administration types between two groups; Other Names: meropenem,MEPEM
OTHER: Control group; meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h	Drug: Meropenem Injection; Different administration types between two groups; Other Names: meropenem,MEPEM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Aihua FEI, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2018
• Primary Completion (ACTUAL): November 14, 2019
• Study Completion (ACTUAL): December 14, 2019

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (ACTUAL): August 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: sepsis，meropenem，2 steps administration
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Anti-Infective Agents; Anti-Bacterial Agents; Meropenem
• Other Study ID Numbers: XH-18-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No