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Standardized Clinical Application of Antibacterial/Anitifungal Drugs

Sponsor
Peking University People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04966390
Collaborator
(none)
5,000
Enrollment
17.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Prospective,Multicenter,Non-interventional Real-world Study for Standardized Clinical Application of Antibacterial/Anitifungal Drugs
    Anticipated Study Start Date :
    Jul 20, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of standardized using of antibacterial/antifungal drugs [approximately 6 months after completion of data collection]

      the proportion of cases who receive standardized antibacterial/antifungal drugs therapy

    2. Clinical efficacy rate [approximately 6 months after completion of data collection]

      the clinical efficacy evaluation of antibacterial/antifungal drugs therapy

    Secondary Outcome Measures

    1. Microbiological efficacy rate [approximately 6 months after completion of data collection]

      the microbiological efficacy evaluation of antibacterial/antifungal drugs therapy

    2. Overall efficacy rate [approximately 6 months after completion of data collection]

      the overall efficacy evaluation of antibacterial/antifungal drugs therapy based on clinical and microbiological efficacy outcome

    3. All-cause mortality [approximately 6 months after completion of data collection]

      the evaluation of all-cause mortality

    4. Antibacterial/antifungal drugs-Related Adverse Events [approximately 6 months after completion of data collection]

      only evaluate of the adverse events related to antibacterial/antifungal drugs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hospitalized patients (≥ 18 years old)

    -≥ 3 days receiving antibacterial/antifungal drugs therapy

    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University People's Hospital

    Investigators

    • Principal Investigator: Youzhong An, Peking University People 's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    An Youzhong, Director of intensive care unit, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT04966390
    Other Study ID Numbers:
    • ANTI
    First Posted:
    Jul 19, 2021
    Last Update Posted:
    Jul 19, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by An Youzhong, Director of intensive care unit, Peking University People's Hospital
    antibacterial/anitifungal drugs
    real world study
    standardized treatment

    Study Results

    No Results Posted as of Jul 19, 2021