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
• Status: Not yet recruiting
• 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
• 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:

-

Related Conditions & MeSH terms

• Antibiotics

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