NCT05862688

Brief Summary

Appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. Inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality. Critically ill intensive care patients are at risk of antibiotic failure and secondary infections associated with incorrect antibiotic use. Initiating effective therapy for infections based upon patients' risk factors, collection of appropriate cultures, daily evaluation of clinical status, and laboratory data, including antibiotic time outs, and shortened duration of therapy are ways to improve patients outcomes. Antimicrobial stewardship teams can assist ICU providers in managing and implementing these tactics. ICUs would benefit from employing empiric guidelines for antibiotic use, collecting appropriate specimens and implementing molecular diagnostics, optimizing the dosing of antibiotics, and reducing the duration of total therapy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

February 26, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
3.1 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 26, 2023

Last Update Submit

February 12, 2026

Conditions

Infections

Outcome Measures

Primary Outcomes (1)

  • survival rate

    the survival rate of children in 21 days after ICU admission

    21 days after ICU admission

Secondary Outcomes (1)

  • the length of ICU stay time

    21 days after ICU admission

Study Arms (2)

Infection

patients with infection

Other: antimicrobial therapy

non-infection

patients without infection

Interventions

antimicrobial therapyOTHER

antimicrobial therapy

Infection

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

ICU patient

You may qualify if:

  • Patients admitted to the ICU for more than 48 hour

You may not qualify if:

  • Patients admitted to ICU less than 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infections

Central Study Contacts

Jing Liu, Doctor

CONTACT

15800523953liujinggg@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2023

First Posted

May 17, 2023

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share