Phase 4
Completed N=79
Meropenem Dosage Strategy Based on PPK Model
Source: ClinicalTrials.gov NCT01944319 ↗Enrolled (actual)
79
Serious AEs
5.1%
Results posted
Feb 2016
Primary outcomePrimary: Clinical Success Rate — 28; 35 participants
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.
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 | — |
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. Informational only — not medical advice.