Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage

NCT ID: NCT03927079

Last Updated: 2025-11-19

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2026-06-01

Brief Summary

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Respiratory infections are common and sometimes very severe. An insufficient dosage of the antibiotic could lead to a treatment failure A correct plasmatic antibiotic concentration is not a guarantee of a clinical success as it could not be a reflect of pulmonary concentration. The aim of this study is to determinate the predictive factors of pulmonary penetration of antibiotics in patients with a beta lactamines failure and who undergoes a flexible bronchoscopy.

Detailed Description

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To check if pulmonary concentrations of antibiotic are enough we will measure antibiotic concentration in the broncho-alveolar lavage (BAL). This technique which is clinically relevant and reliable could determinate the pulmonary diffusion level for antibiotics by calculating the ratio between plasmatic and intra-alveolar antibiotic concentration. This ratio will be correlated with potential limitation factors of pulmonary diffusion as respiratory diseases (COPD, cystic fibrosis, fibrosis…), sepsis, hypoalbuminemia. We have chosen to study the beta lactamin antibiotics because they are the most frequently used in pneumonia. Moreover, the beta lactamins pulmonary diffusion is likely to be the lowest. Finally, for patients with a known pathogen, we will divide this pulmonary concentration with minimal inhibitory concentration (MIC). Indeed, in severe pneumonia, to be sure of bactericidal activity, a pulmonary concentration of beta lactamines should be always higher than 4 to 5 times MIC.

Conditions

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Antibiotics Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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measure of intra-alveolar antibiotic concentration in µg/ml

included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration

Intervention Type BIOLOGICAL

broncho-alveolar lavage (BAL)

included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration

Intervention Type PROCEDURE

blood test to measure plasmatic antibiotic concentration in µg/ml

included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* patients who undergo a flexible bronchoscopic lavage and with a beta lactamines treatment as cephalosporin of 3rd generation (CEFTRIAXONE / CEFOTAXIME, CEFTAZIDIME), of 4th generation (CEFEPIM), or AMOXICILLIN-CLAVULANIC ACID, or PIPERACILLIN-TAZOBACTAM
* patient major
* informed and signed consent form

Exclusion Criteria

* patient under chronic dialysis
* patient placed under judicial protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Andrejak, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2018_843_0032

Identifier Type: -

Identifier Source: org_study_id

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