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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Antibiotics
• Intervention / Treatment: Biological: measure of intra-alveolar antibiotic concentration in µg/ml; Procedure: broncho-alveolar lavage (BAL); Biological: blood test to measure plasmatic antibiotic concentration in µg/ml

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: claire Andrejak, Pr; Phone Number: (33)3 22 08 78 93; Email: andrejak.claire@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary diffusion level for beta lactamins	pulmonary diffusion level for beta lactamins is determined by ratio between bronchoalveolar concentration and plasmatic concentration of tested antibiotics	on the day of the bronco-alveolar lavage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure of apyrexia duration in days	measure of apyrexia duration in days	from day of inclusion to 15 days after inclusion
duration in days for regression of the biological inflammatory syndrome	duration in days for regression of the biological inflammatory syndrome (CRP concentration in mg/l divided by 2)	from day of inclusion to 15 days after inclusion
measure of length of hospitalisation	measure of length of hospitalisation in days	from day of inclusion to 15 days after inclusion
Number of deaths at 28-day	28-day mortality will be measured	28 days after inclusion
virus presence in BAL	virus presence will be detected in bronchoalveolar lavage (BAL)	day of bronchoalveolar lavage (BAL)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Claire Andrejak, Pr, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pneumonia; Antibiotics; broncho-alveolar lavage
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antitubercular Agents; Chelating Agents; Sequestering Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular; Dimercaprol
• Other Study ID Numbers: PI2018_843_0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No