NCT04987840

Brief Summary

The objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
13mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
enrolling by invitation

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

Study Progress82%
May 2021Jun 2027

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

July 28, 2021

Last Update Submit

January 13, 2026

Conditions

Keywords

Diagnostic StewardshipPediatricRespiratory Culture Test

Outcome Measures

Primary Outcomes (1)

  • Respiratory Culture Rate

    Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month

    up to 42 months

Secondary Outcomes (9)

  • Broad spectrum antibiotic use for ICU days >2 days

    up to 42 months

  • New initiations - Broad spectrum antibiotic use for ICU days >2 days

    up to 42 months

  • Mortality

    up to 42 months

  • Length of ICU stay

    up to 42 months

  • ICU readmission

    up to 42 months

  • +4 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patient populations from units that develop and implement a quality improvement program to reduce respiratory culture use

You may qualify if:

  • Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

You may not qualify if:

  • Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Minnesota Hospital

Minneapolis, Minnesota, 55404, United States

Location

Children's Hospital and Medical Center Omaha

Omaha, Nebraska, 68114, United States

Location

Cleveland Clinic Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Monroe Carell Jr. Children's Hospital

Nashville, Tennessee, 37232, United States

Location

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aaron Milstone, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 3, 2021

Study Start

May 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations