E Test Strips Applied to Bronchoalveolar Lavage for Suspi... | NCT01266863

Studies
E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.

NCT01266863

Sponsor

Université Victor Segalen Bordeaux 2

Status

Completed

Last Update Posted

Jun 10, 2015Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Hospital-acquired Pneumonia

Interventions

E test method

Countries

France

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Nov 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 22, 2010

First Submission Date that Met QC Criteria

Dec 23, 2010

First Posted Date

Dec 24, 2010Estimated

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

Jun 9, 2015

Last Update Posted Date

Jun 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandre Boyer, Medical doctor, Université Victor Segalen Bordeaux 2Principal Investigator

Lead Sponsor

Université Victor Segalen Bordeaux 2OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.

Detailed Description

Not provided

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E test method	Experimental		Other: E test method

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E test method	Other	E test strips directly applied to BAL	E test method

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major error defined as the MIC(s) classified as R or I by E test method and S by referent method		2 days

Secondary Outcomes

Measure	Description	Time Frame
Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method		2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients with suspected HAP undergoing BAL will be eligible

Exclusion Criteria:

contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.

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

Facility	Status	City	State	ZIP	Country	Contacts
CHU Bordeaux		Bordeaux		33000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30538161	Derived	Boyer A, Goret J, Clouzeau B, Romen A, Prevel R, Lhomme E, Vargas F, Hilbert G, Bebear C, Gruson D, M'Zali F. Tailoring Empirical Antimicrobial Therapy in Subjects With Ventilator-Associated Pneumonia With a 10-Hour E-Test Approach. Respir Care. 2019 Mar;64(3):307-312. doi: 10.4187/respcare.06255. Epub 2018 Dec 11.

ID	Term
D003428	Cross Infection
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections