Meropenem Dosage Strategy Based on PPK Model

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Respiratory Tract Infection
• Intervention / Treatment: Drug: Routine meropenem therapy; Drug: Meropenem therapy based on a PPK and PD model

Detailed Description

• 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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Haidian District, Beijing, China, 100191
      • Peking University Third Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; The participants in control group will accept routine meropenem therapy	Drug: Routine meropenem therapy; Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician; Other Names: Standard care
Experimental: Study group; The participants in study group will accept meropenem therapy based on a PPK and PD model.	Drug: Meropenem therapy based on a PPK and PD model; Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model; Other Names: Experimental meropenem therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success Rate	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.	One week after antibiotic therapy finished.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Used Antibiotics	Record the amount of antibiotics usage during antibiotic therapy	participants will be followed for the duration of antibiotic therapy, an average of 10 days
Bacteriological Success Rate	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.	At the end of meropenem therapy, an average of 10 days.

Collaborators and Investigators

• Sponsor: Qingtao Zhou
• Investigators: Principal Investigator: Qingtao Zhou, M.D., Peking University Third Hospital

Publications and helpful links

General Publications

• Zhou QT, He B, Shen N, Liang Y, Sun LN. Meropenem Dosing Based on a Population Pharmacokinetic-Pharmacodynamic Model in Elderly Patients with Infection of the Lower Respiratory Tract. Drugs Aging. 2017 Feb;34(2):115-121. doi: 10.1007/s40266-016-0431-9.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections; Anti-Infective Agents; Anti-Bacterial Agents; Meropenem
• Other Study ID Numbers: 75505-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO