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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of standardized using of antibacterial/antifungal drugs | the proportion of cases who receive standardized antibacterial/antifungal drugs therapy | approximately 6 months after completion of data collection |
| Clinical efficacy rate | the clinical efficacy evaluation of antibacterial/antifungal drugs therapy | approximately 6 months after completion of data collection |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological efficacy rate | the microbiological efficacy evaluation of antibacterial/antifungal drugs therapy | approximately 6 months after completion of data collection |
| Overall efficacy rate |
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Inclusion Criteria:
- Hospitalized patients (≥ 18 years old)
-≥ 3 days receiving antibacterial/antifungal drugs therapy
Exclusion Criteria:
-
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This research plans to enroll 5000 hospitalized patients (≥ 18 years old with infectious disease), who use antibacterial/antifungal drugs for more than 3 days. Patients mainly come from ICU, respiratory department and hematology department.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuguang Yang | Contact | +86 13051703401 | rwsycb@163.com | |
| Youzhong An | Contact | +86 13701039925 | youzhonganicu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Youzhong An | Peking University People 's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41422100 | Derived | Yang S, Sun Y, Wang T, Hao C, Zhang H, Sun W, An Y, Zhao H. Machine learning-based prediction of mortality and multidrug-resistant infection risks in ICU patients with suspected infection: a prospective national multicenter cohort study. BMC Infect Dis. 2025 Dec 20;26(1):139. doi: 10.1186/s12879-025-12354-8. |
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the overall efficacy evaluation of antibacterial/antifungal drugs therapy based on clinical and microbiological efficacy outcome
| approximately 6 months after completion of data collection |
| All-cause mortality | the evaluation of all-cause mortality | approximately 6 months after completion of data collection |
| Antibacterial/antifungal drugs-Related Adverse Events | only evaluate of the adverse events related to antibacterial/antifungal drugs | approximately 6 months after completion of data collection |