A Cohort Study on Anti-microbial Stewardship in PICU

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862688
Collaborator
(none)
1,000
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: antimicrobial therapy

Detailed Description

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. This study conducted an antibiotic management cohort study in PICUs to discover the distribution of nosocomial infections in PICUs and to find controllable factors for the occurrence of nosocomial infections.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Cohort Study on Anti-microbial Stewardship in PICU
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Infection

patients with infection

Other: antimicrobial therapy
antimicrobial therapy

non-infection

patients without infection

Outcome Measures

Primary Outcome Measures

  1. survival rate [21 days after ICU admission]

    the survival rate of children in 21 days after ICU admission

Secondary Outcome Measures

  1. the length of ICU stay time [21 days after ICU admission]

    the length of ICU stay time

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients admitted to the ICU for more than 48 hour
Exclusion Criteria:
  • Patients admitted to ICU less than 48 hours

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Children's Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT05862688
Other Study ID Numbers:
  • fdpicu-29
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023