Anti-Infective Agent
Conditions
Keywords
Anti-Infective Agent
Brief summary
Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the clinical efficacy of different administration schedules of CAZ/AVI for patients with severe infection, and further analyze the correlation between CAZ/AVI PK/PD parameters and clinical efficacy and adverse reactions.
Detailed description
1. Main purpose The main objective of this study was to verify that the clinical efficacy of treatment group (load dose of 2.5g, then continuous infusion of 2.5gQ8h, the dose can be adjusted according to renal function) with severe infection was superior to that of the control group (standard dose and administration regimen of ceftazidime/avibactam, i.e. 2.5gQ8h, 2h infusion).Dose can be adjusted according to renal function). 2. Secondary purpose (1) To investigate the relationship between different administration regimens and bacterial clearance and 28-d mortality (2) To explore the correlation between different dosing regimens and PK/PD compliance rate (3) To explore the correlation between different administration regimens and adverse drug reactions
Interventions
DRUGCAZ/AVI
continuous infusion is used
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
A non-blind study
Intervention model description
Treatment group and control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Multiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam
Exclusion criteria
Allergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical effective rate | 14 days | According to the Technical Guidelines for Clinical Trials of Antimicrobial Drugs, clinical efficacy is defined as: (1) effective: symptoms, signs, pathogenic microbiology and various tests and examination indicators are significantly improved;(2) Ineffective: the patient's condition has not improved or worsened, and other antibacterial drugs need to be replaced.Effective rate = Number of effective cases/total cases x 100%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial removal | 14 days | Defined as clearance or change of existing bacteria within two weeks of medication. |
| 28-d mortality | 28 days | Defined as whether a patient died at 28-d after follow-up.28-d Mortality rate = Number of deaths/group size x 100%. |
| PK/PD compliance rate | 14 days | PK/PD compliance rate = number of qualified persons/number of groups × 100%. |
Countries
China
Contacts
Primary ContactYing Xu, Ph.D
Outcome results
None listed