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

Not Applicable

Completed

• Conditions: Pneumonia; Antibiotics

• Registration Number: NCT03927079
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

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 Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-25
• Primary Completion: 2022-04-01
• Study Completion: 2023-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France