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.

• 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.

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.