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

Pneumonia Clinical Trial

— ABBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927079
• Other study ID #: PI2018_843_0032
• Status: Completed
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotics
• Pneumonia

Intervention

Biological:
• 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

Procedure:
• 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

Biological:
• 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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	measure of apyrexia duration in days	measure of apyrexia duration in days	from day of inclusion to 15 days after inclusion
Secondary	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
Secondary	measure of length of hospitalisation	measure of length of hospitalisation in days	from day of inclusion to 15 days after inclusion
Secondary	Number of deaths at 28-day	28-day mortality will be measured	28 days after inclusion
Secondary	virus presence in BAL	virus presence will be detected in bronchoalveolar lavage (BAL)	day of bronchoalveolar lavage (BAL)