Phase 4
N=79
Meropenem Dosage Strategy Based on PPK Model
Lower Respiratory Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01944319 ↗Enrolled (actual)
79
Serious AEs
5.1%
Results posted
Feb 2016
Primary outcome: Primary: Clinical Success Rate — 28; 35 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Routine meropenem therapy (Drug); Meropenem therapy based on a PPK and PD model (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Qingtao Zhou
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success Rate |
28; 35 | — |
| SECONDARY Amount of Used Antibiotics |
19.0; 15.0 | — |
| SECONDARY Bacteriological Success Rate |
24; 28 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01944319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.