NCT04966390

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

July 14, 2021

Last Update Submit

July 14, 2021

Conditions

Antibiotics

Keywords

antibacterial/anitifungal drugsreal world studystandardized treatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • Clinical efficacy rate

    the clinical efficacy evaluation of antibacterial/antifungal drugs therapy

    approximately 6 months after completion of data collection

Secondary Outcomes (4)

  • Microbiological efficacy rate

    approximately 6 months after completion of data collection

  • Overall efficacy rate

    approximately 6 months after completion of data collection

  • All-cause mortality

    approximately 6 months after completion of data collection

  • Antibacterial/antifungal drugs-Related Adverse Events

    approximately 6 months after completion of data collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- Hospitalized patients (≥ 18 years old)
  • ≥ 3 days receiving antibacterial/antifungal drugs therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Youzhong An

    Peking University People 's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuguang Yang

CONTACT

+86 13051703401rwsycb@163.com

Youzhong An

CONTACT

+86 13701039925youzhonganicu@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of intensive care unit

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 19, 2021

Study Start

July 20, 2021

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

July 19, 2021

Record last verified: 2021-07