Antibiotics
Conditions
Keywords
antibacterial/anitifungal drugs, real world study, standardized treatment
Brief summary
The purpose of this real world study is to observe the clinical status for standardized using of antibacterial/anitifungal drugs in patients with infection,and to evaluate the efficacy and safety of anti-infection therapy.
Detailed description
This study is a prospective,multicenter,non-interventional real-world study.The purpose of this study is to observe the clinical status of infection patients under standardized application of antibacterial/anitifungal drugs,and to evaluate the efficacy and safety of anti-infection treatment. This study plans to enroll 5000 hospitalized patients (≥ 18 years old with infectious disease),who take antibacterial/anitifungal drugs for more than 3 days. Patients mainly come from ICU,Respiratory Department and Hematology Department. The clinical data collection is divided into five parts,including Baseline,3rd and 7th day after the first dosing of antibacterial/anitifungal drugs,End of antibacterial/anitifungal drugs treatment (EOT),14th day after EOT. The collected clinical data cover general characteristics,condition assessment and severity evaluation,pathogenic diagnosis,the use of antibacterial/antifungal drugs,antibacterial/antifungal drugs-related adverse events,et al. After completing the collection of case data, the proportion analysis, efficacy evaluation and safety evaluation for the standardized application of antibacterial/antifungal drugs will be carried out.
Interventions
None listed
Sponsors
Peking University People's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Hospitalized patients (≥ 18 years old) -≥ 3 days receiving antibacterial/antifungal drugs therapy
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of standardized using of antibacterial/antifungal drugs | approximately 6 months after completion of data collection | the proportion of cases who receive standardized antibacterial/antifungal drugs therapy |
| Clinical efficacy rate | approximately 6 months after completion of data collection | the clinical efficacy evaluation of antibacterial/antifungal drugs therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological efficacy rate | approximately 6 months after completion of data collection | the microbiological efficacy evaluation of antibacterial/antifungal drugs therapy |
| Overall efficacy rate | approximately 6 months after completion of data collection | the overall efficacy evaluation of antibacterial/antifungal drugs therapy based on clinical and microbiological efficacy outcome |
| All-cause mortality | approximately 6 months after completion of data collection | the evaluation of all-cause mortality |
| Antibacterial/antifungal drugs-Related Adverse Events | approximately 6 months after completion of data collection | only evaluate of the adverse events related to antibacterial/antifungal drugs |
Contacts
Primary ContactShuguang Yang
Backup ContactYouzhong An
Outcome results
None listed