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

NCT ID: NCT01266863

Last Updated: 2015-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Hospital-acquired Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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E test method

Group Type EXPERIMENTAL

E test method

Intervention Type OTHER

E test strips directly applied to BAL

Interventions

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E test method

E test strips directly applied to BAL

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Victor Segalen Bordeaux 2

OTHER

Sponsor Role lead

Responsible Party

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Alexandre Boyer

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30538161 (View on PubMed)

Other Identifiers

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ABoyer3

Identifier Type: -

Identifier Source: org_study_id

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