Standardized Clinical Application of Antibacterial/Anitifungal Drugs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective,Multicenter,Non-interventional Real-world Study for Standardized Clinical Application of Antibacterial/Anitifungal Drugs

Conditions
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Antibiotics

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Hospitalized patients (≥ 18 years old) -≥ 3 days receiving antibacterial/antifungal drugs therapy Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibacterial/anitifungal drugs, real world study, standardized treatment