Clinical trial NCT01944319: Meropenem Dosage Strategy Based on PPK Model
Official title: Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Respiratory Tract Infection
Keywords: Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 79
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success Rate
timeFrame: One week after antibiotic therapy finished.
Secondary outcomes:
measure: Amount of Used Antibiotics
timeFrame: participants will be followed for the duration of antibiotic therapy, an average of 10 days
measure: Bacteriological Success Rate
timeFrame: At the end of meropenem therapy, an average of 10 days.
Other outcomes:
Locations:
city: Haidian District
country: China
facility: Peking University Third Hospita
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qingtao Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou QT, He B, Shen N, Liang Y, Sun LN. Meropenem Dosing Based on a Population Pharmacokinetic-Pharmacodynamic Model in Elderly Patients with Infection of the Lower Respiratory Tract. Drugs Aging. 2017 Feb;34(2):115-121. doi: 10.1007/s40266-016-0431-9.