Sepsis
Conditions
Keywords
sepsis，meropenem，2 steps administration
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.
Interventions
Different administration types between two groups
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T>MIC | Day 1 | Time above MIC% per administration interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| SOFA | Day 0,Day 4,Day 8 | Change of Sepsis-related Organ Failure Assessment score (sofa) during period of treatment |
Countries
China
Outcome results
None listed