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Completed

NCT Number: NCT03645668

Efficacy and Pharmacokinetics of Meropenem in Severe Septic Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meropenem Injection

Drug

Different administration types between two groups

Other names: meropenem,MEPEM

Primary outcomes

  1. T>MIC

    Time frame: Day 1

    Time above MIC% per administration interval

Secondary outcomes

  1. APACHE II score

    Time frame: Day 0,Day 4,Day 8

    Change of Acute physiology and chronic health evaluation score (APACHE II score) during period of treatment

  2. SOFA

    Time frame: Day 0,Day 4,Day 8

    Change of Sepsis-related Organ Failure Assessment score (sofa) during period of treatment

  3. Mortality

    Time frame: Day 28

    Mortality within 28 days

  4. highest temperature

    Time frame: Day 0,Day 4,Day 8

    Variation of the highest temperature

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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