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NCT Number: NCT01944319

Meropenem Dosage Strategy Based on PPK Model

To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients.

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Key information

Conditions

Lower Respiratory Tract Infection Infections

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Third Hospita

Haidian District, Beijing Municipality, 100191, China

About this study

  • Subjects:lower respiratory tract infection patients
  • Study design:randomized control study.The patients in study group will accept meropenem therapy with the regimen decided by a software developed from a PPK-PD model. The patients in control group will accept meropenem therapy with the regimen decided by attending physician.
  • Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency of meropenem therapy will be evaluated one week later from stop of meropenem therapy.
  • Second endpoint: amount of used antibiotics and bacteriological successful rate.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sixty years and older patients hospitalized at the Peking University Third Hospital with community-acquired or hospital-acquired lower respiratory tract infection.
  • Bacilli was idolated from lower respiratory tract specimens within 48 hours prior to study enrollment.
  • The pathogen was sensitive to meropenem.
  • Received broad-spectrum antibiotic therapy less than 24 hours, or no improvement after antibiotic therapy and pathogen was resistant to the used antibiotics.

Exclusion criteria

  • Had documented hypersensitivity to carbapenems.
  • More than one pathogenic Gram-negative bacillus was isolated lower respiratory tract specimens.
  • Positive HIV antibody titre.
  • Had known or suspected tuberculosis or other infections caused by Gram-positive cocci, viruses or fungi at baseline.

Treatment and study plan

Routine meropenem therapy

Drug

Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician

Other names: Standard care

Meropenem therapy based on a PPK and PD model

Drug

Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model

Other names: Experimental meropenem therapy

Primary outcomes

  1. Clinical Success Rate

    Time frame: One week after antibiotic therapy finished.

    The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy.

    Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy.

    Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy.

Secondary outcomes

  1. Amount of Used Antibiotics

    Time frame: participants will be followed for the duration of antibiotic therapy, an average of 10 days

    Record the amount of antibiotics usage during antibiotic therapy

  2. Bacteriological Success Rate

    Time frame: At the end of meropenem therapy, an average of 10 days.

    The bacterial success or failure will be evaluated at the end of meropenem therapy.

    Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence.

Sponsors and collaborators

Lead sponsor

Qingtao Zhou

Other

Registry information

Official study title

Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2013
Registry last updated
Feb 25, 2016

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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