Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

NCT03645668 | Completed Phase 4

• 1 other identifier: XH-18-003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis

Keywords

sepsis，meropenem，2 steps administration

Outcome Measures

Primary Outcomes (1)

• T>MIC

  Time above MIC% per administration interval

  Day 1

Secondary Outcomes (4)

• APACHE II score

  Day 0,Day 4,Day 8

• SOFA

  Day 0,Day 4,Day 8

• Mortality

  Day 28

• highest temperature

  Day 0,Day 4,Day 8

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Meropenem Injection

Control group

OTHER

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

Drug: Meropenem Injection

Interventions

Meropenem Injection DRUG

Different administration types between two groups

Also known as: meropenem,MEPEM

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients, whose informed consent has been obtained;
• Clinical diagnosis of Sepsis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Sepsis

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Aihua FEI

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: August 24, 2018
• Study Start: January 30, 2018
• Primary Completion: November 14, 2019
• Study Completion: December 14, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

CN (1)