Clinical trial NCT04966390: Standardized Clinical Application of Antibacterial/Anitifungal Drugs
Official title: A Prospective,Multicenter,Non-interventional Real-world Study for Standardized Clinical Application of Antibacterial/Anitifungal Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibiotics
Keywords: antibacterial/anitifungal drugs
real world study
standardized treatment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

- Hospitalized patients (≥ 18 years old)

-≥ 3 days receiving antibacterial/antifungal drugs therapy

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of standardized using of antibacterial/antifungal drugs
timeFrame: approximately 6 months after completion of data collection
measure: Clinical efficacy rate
timeFrame: approximately 6 months after completion of data collection
Secondary outcomes:
measure: Microbiological efficacy rate
timeFrame: approximately 6 months after completion of data collection
measure: Overall efficacy rate
timeFrame: approximately 6 months after completion of data collection
measure: All-cause mortality
timeFrame: approximately 6 months after completion of data collection
measure: Antibacterial/antifungal drugs-Related Adverse Events
timeFrame: approximately 6 months after completion of data collection
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People 's Hospital
name: Youzhong An
role: PRINCIPAL_INVESTIGATOR
References: