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NCT04966390 Clinical Trial

Standardized Clinical Application of Antibacterial/Anitifungal Drugs

Antibiotics Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04966390
Other study ID # ANTI
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 20, 2021
Est. completion date December 31, 2022

Study information
Verified date July 2021
Source Peking University People's Hospital
Contact Shuguang Yang
Phone +86 13051703401
Email rwsycb@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 5000
Est. completion date December 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hospitalized patients (= 18 years old) -= 3 days receiving antibacterial/antifungal drugs therapy Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Clinical efficacy rate the clinical efficacy evaluation of antibacterial/antifungal drugs therapy approximately 6 months after completion of data collection
Secondary Microbiological efficacy rate the microbiological efficacy evaluation of antibacterial/antifungal drugs therapy approximately 6 months after completion of data collection
Secondary 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
Secondary All-cause mortality the evaluation of all-cause mortality approximately 6 months after completion of data collection
Secondary 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
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