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Meropenem Dosage Strategy Based on PPK Model

Primary Purpose

Lower Respiratory Tract Infection

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Routine meropenem therapy
Meropenem therapy based on a PPK and PD model
Sponsored by
Qingtao Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Respiratory Tract Infection focused on measuring Infection; Meropenem; Pharmacokinetics; Pharmacodynamics

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Third Hospita

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Study group

Arm Description

The participants in control group will accept routine meropenem therapy

The participants in study group will accept meropenem therapy based on a PPK and PD model.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Amount of Used Antibiotics
Record the amount of antibiotics usage during antibiotic therapy
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.

Full Information

First Posted
July 2, 2013
Last Updated
January 28, 2016
Sponsor
Qingtao Zhou
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1. Study Identification

Unique Protocol Identification Number
NCT01944319
Brief Title
Meropenem Dosage Strategy Based on PPK Model
Official Title
Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qingtao Zhou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Respiratory Tract Infection
Keywords
Infection; Meropenem; Pharmacokinetics; Pharmacodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The participants in control group will accept routine meropenem therapy
Arm Title
Study group
Arm Type
Experimental
Arm Description
The participants in study group will accept meropenem therapy based on a PPK and PD model.
Intervention Type
Drug
Intervention Name(s)
Routine meropenem therapy
Other Intervention Name(s)
Standard care
Intervention Description
Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician
Intervention Type
Drug
Intervention Name(s)
Meropenem therapy based on a PPK and PD model
Other Intervention Name(s)
Experimental meropenem therapy
Intervention Description
Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model
Primary Outcome Measure Information:
Title
Clinical Success Rate
Description
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.
Time Frame
One week after antibiotic therapy finished.
Secondary Outcome Measure Information:
Title
Amount of Used Antibiotics
Description
Record the amount of antibiotics usage during antibiotic therapy
Time Frame
participants will be followed for the duration of antibiotic therapy, an average of 10 days
Title
Bacteriological Success Rate
Description
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.
Time Frame
At the end of meropenem therapy, an average of 10 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingtao Zhou, M.D.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospita
City
Haidian District
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28097633
Citation
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.
Results Reference
derived

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Meropenem Dosage Strategy Based on PPK Model

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