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Meropenem Dosage Strategy Based on PPK Model

Q

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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