Use of a Rapid Diagnostic Test for Antibiotic De-escalati... | NCT04781829

Studies
Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia

NCT04781829

Sponsor

Northwestern University

Status

Withdrawn

Last Update Posted

Mar 4, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Community-acquired Pneumonia

Interventions

BioFire Pneumonia Panel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID pandemic precluded trial initiation. No longer clinical equipoise

Expanded Access Info

Start Date

Jan 15, 2020Estimated

Primary Completion Date

Jan 15, 2021Estimated

Completion Date

Feb 15, 2021Estimated

First Submitted Date

Mar 1, 2021

First Submission Date that Met QC Criteria

Mar 1, 2021

First Posted Date

Mar 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (SCAP). We hypothesize that when results from a rapid diagnostic test (RDT) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Critically ill patients with pneumonia will be treated with an antibiotic strategy at the discretion of the treating clinician
Interventional	Experimental	Critically ill patients with pneumonia will be treated with an antibiotic strategy based on results from the BioFire Pneumonia Panel	Diagnostic Test: BioFire Pneumonia Panel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BioFire Pneumonia Panel	Diagnostic Test	Treatment based on an algorithm that recommends antibiotic choices based on bacteria/virus detected by BioFire Pneumonia Panel	Interventional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Narrow-spectrum Antibiotic Treatment	A quantitative tool that reflects how broad or narrow antibiotic is	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 18 years and older with known or suspected community-acquired pneumonia who are admitted to the MICU Service
Meets one of the following:
1. Have or plan to obtain a bronchoalveolar lavage (BAL)
2. Have or plan to obtain a quantitative endotracheal aspirate sample
3. Have already produced a high-quality sputum sample if not intubated
Primary MICU attending and fellow willing to base antibiotic therapy on results of RDT

Exclusion Criteria:

Subjects with confirmed extrapulmonary infection requiring antibiotics outside the usual treatment for SCAP, with the exception of suspected uncomplicated urinary tract infection
Neutropenic fever, defined as absolute neutrophil count <1000/mm3 and absence of infiltrate on available chest imaging
Chronic airway infection, defined as cystic fibrosis, lung transplant, or non-CF bronchiectasis
Patient/surrogate refusal
Inability to perform BAL, NBBAL, quantitative ETA, or produce a high-quality sputum sample prior to 48 hours from hospital admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000098968	Community-Acquired Pneumonia

Ancestor Terms

ID	Term
D017714	Community-Acquired Infections
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided