Standardized Clinical Application of Antibacterial/Anitifungal Drugs

NCT ID: NCT04966390

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-20

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Antibiotics

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\- Hospitalized patients (≥ 18 years old)

-≥ 3 days receiving antibacterial/antifungal drugs therapy

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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An Youzhong

Director of intensive care unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youzhong An

Role: PRINCIPAL_INVESTIGATOR

Peking University People 's Hospital

Central Contacts

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Shuguang Yang

Role: CONTACT

+86 13051703401

Youzhong An

Role: CONTACT

+86 13701039925

Other Identifiers

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ANTI

Identifier Type: -

Identifier Source: org_study_id

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