An observational study in Antibiotics, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-19.
Sponsored by Peking University People's Hospital · Observational
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.
Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
-≥ 3 days receiving antibacterial/antifungal drugs therapy
Exclusion Criteria:
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Proportion of standardized using of antibacterial/antifungal drugs
the proportion of cases who receive standardized antibacterial/antifungal drugs therapy
Time frame: approximately 6 months after completion of data collection
Clinical efficacy rate
the clinical efficacy evaluation of antibacterial/antifungal drugs therapy
Time frame: approximately 6 months after completion of data collection
Microbiological efficacy rate
the microbiological efficacy evaluation of antibacterial/antifungal drugs therapy
Time frame: 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
Time frame: approximately 6 months after completion of data collection
All-cause mortality
the evaluation of all-cause mortality
Time frame: 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
Time frame: approximately 6 months after completion of data collection
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital