Standardized Clinical Application of Antibacterial/Anitifungal Drugs
- Conditions
- Antibiotics
- Registration Number
- NCT04966390
- Lead Sponsor
- Peking University People's Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 5000
- Hospitalized patients (≥ 18 years old)
-≥ 3 days receiving antibacterial/antifungal drugs therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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