Meropenem Dosage Strategy Based on PPK Model

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Population Pharmacokinetics of Meropenem and Linezolid in Children With Severe Infectious Diseases

NCT03643497

Children；Infection

UNKNOWN

Translational PKPD Modeling of Anti-infective Drugs Used in Pediatric Units.

NCT05426499

Population Modeling of Anti-infective Drugs

RECRUITING

To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944

NCT01934205

Infections, Bacterial

COMPLETED PHASE1

Effect of Age and Gender on the PK and Tolerability of Finafloxacin

NCT01904162

Pharmacokinetic and Tolerability of Finafloxacin

COMPLETED PHASE1

Population Pharmacokinetics of Cephalosporins and Macrolides in Chinese Children With Community Acquired Pneumonia

NCT02775968

Community Acquired Pneumonia

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Respiratory Tract Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

The participants in control group will accept routine meropenem therapy

Group Type ACTIVE_COMPARATOR

Routine meropenem therapy

Intervention Type DRUG

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

Study group

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

Group Type EXPERIMENTAL

Meropenem therapy based on a PPK and PD model

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Routine meropenem therapy

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Standard care Experimental meropenem therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No