NCT04966390

Standardized Clinical Application of Antibacterial/Anitifungal Drugs

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antibiotics

Timeline

• Start date: 2021-07-20
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2021-07-19
• Last updated: 2021-07-19