Meropenem Dosage Strategy Based on PPK Model

Qingtao Zhou

Status and phase: Completed; Phase 4

Conditions: Lower Respiratory Tract Infection

Treatments: Drug: Routine meropenem therapy; Drug: Meropenem therapy based on a PPK and PD model

Study type: Interventional

Funder types: Other

Identifiers

NCT01944319

75505-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 60 to 95 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Control group

Active Comparator group

Description:

The participants in control group will accept routine meropenem therapy

Treatment:

Drug: Routine meropenem therapy

Study group

Experimental group

Description:

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

Treatment:

Drug: Meropenem therapy based on a PPK and PD model