NCT01944319

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Qingtao Zhou · Academic / Other
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Respiratory Tract Infection

Interventions

Type	Name	Description
DRUG	Routine meropenem therapy	Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician
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

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-09-17
• Last updated: 2016-02-25
• Results posted: 2016-02-25

Locations

1 site across 1 country: China