Lower Respiratory Tract Infection
Conditions
Keywords
Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
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.
Interventions
DRUGRoutine meropenem therapy
Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician
DRUGMeropenem therapy based on a PPK and PD model
Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model
Sponsors
Qingtao Zhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate | One week after antibiotic therapy finished. | The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy. Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy. Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Used Antibiotics | participants will be followed for the duration of antibiotic therapy, an average of 10 days | Record the amount of antibiotics usage during antibiotic therapy |
| Bacteriological Success Rate | At the end of meropenem therapy, an average of 10 days. | The bacterial success or failure will be evaluated at the end of meropenem therapy. Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Meropenem therapy with regimen routinely decided by attending physician | 40 |
| Study Group Patients in Study group will accept meropenem therapy based on PPK and PD parameter.
Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter | 39 |
| Total | 79 |
Baseline characteristics
| Characteristic | Control Group | Study Group | Total |
|---|---|---|---|
| Age, Continuous | 79 years | 78 years | 79 years |
| Region of Enrollment China | 40 participants | 39 participants | 79 participants |
| Sex: Female, Male Female | 16 Participants | 10 Participants | 26 Participants |
| Sex: Female, Male Male | 24 Participants | 29 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 39 |
| serious Total, serious adverse events | 4 / 40 | 0 / 39 |
Outcome results
Primary
Clinical Success Rate
The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy. Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy. Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy.
Time frame: One week after antibiotic therapy finished.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Clinical Success Rate | 28 participants |
| Study Group | Clinical Success Rate | 35 participants |
Secondary
Amount of Used Antibiotics
Record the amount of antibiotics usage during antibiotic therapy
Time frame: participants will be followed for the duration of antibiotic therapy, an average of 10 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Amount of Used Antibiotics | 19.0 grams |
| Study Group | Amount of Used Antibiotics | 15.0 grams |
Secondary
Bacteriological Success Rate
The bacterial success or failure will be evaluated at the end of meropenem therapy. Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence.
Time frame: At the end of meropenem therapy, an average of 10 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Bacteriological Success Rate | 24 participants |
| Study Group | Bacteriological Success Rate | 28 participants |