Meropenem Dosage Strategy Based on PPK Model

Phase 4CompletedNCT01944319

Qingtao Zhou79 enrolled

Overview

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.

* 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Respiratory Tract Infection

Interventions

Routine meropenem therapyDRUG

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

Meropenem therapy based on a PPK and PD modelDRUG

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 95 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University Third Hospita

Haidian District, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: One week after antibiotic therapy finished.

Secondary Outcomes

Amount of Used Antibiotics

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

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.

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

Data from ClinicalTrials.gov

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