Back to resultsEfficacy and Pharmacokinetics of Meropenem in Severe Septic Patients
Primary Purpose
Sepsis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Meropenem Injection
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring sepsis，meropenem，2 steps administration
Eligibility Criteria
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.
Sites / Locations
- Shanghai Xinhua Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental group
Control group
Arm Description
meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h
meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h
Outcomes
Primary Outcome Measures
T>MIC
Time above MIC% per administration interval
Secondary Outcome Measures
APACHE II score
Change of Acute physiology and chronic health evaluation score (APACHE II score) during period of treatment
SOFA
Change of Sepsis-related Organ Failure Assessment score (sofa) during period of treatment
Mortality
Mortality within 28 days
highest temperature
Variation of the highest temperature
Full Information
NCT ID
NCT03645668
First Posted
February 7, 2018
Last Updated
March 11, 2020
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03645668
Brief Title
Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients
Official Title
Efficacy and Pharmacokinetics of Meropenem in Different Administration for Patients With Severe Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
December 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
sepsis，meropenem，2 steps administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h
Arm Title
Control group
Arm Type
Other
Arm Description
meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h
Intervention Type
Drug
Intervention Name(s)
Meropenem Injection
Other Intervention Name(s)
meropenem,MEPEM
Intervention Description
Different administration types between two groups
Primary Outcome Measure Information:
Title
T>MIC
Description
Time above MIC% per administration interval
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
APACHE II score
Description
Change of Acute physiology and chronic health evaluation score (APACHE II score) during period of treatment
Time Frame
Day 0,Day 4,Day 8
Title
SOFA
Description
Change of Sepsis-related Organ Failure Assessment score (sofa) during period of treatment
Time Frame
Day 0,Day 4,Day 8
Title
Mortality
Description
Mortality within 28 days
Time Frame
Day 28
Title
highest temperature
Description
Variation of the highest temperature
Time Frame
Day 0,Day 4,Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aihua FEI
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients
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