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

Primary Purpose

Antibiotics, Pneumonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
measure of intra-alveolar antibiotic concentration in µg/ml
broncho-alveolar lavage (BAL)
blood test to measure plasmatic antibiotic concentration in µg/ml
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Antibiotics focused on measuring Antibiotics, Pneumonia, broncho-alveolar lavage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

measure of apyrexia duration in days
measure of apyrexia duration in days
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)
measure of length of hospitalisation
measure of length of hospitalisation in days
Number of deaths at 28-day
28-day mortality will be measured
virus presence in BAL
virus presence will be detected in bronchoalveolar lavage (BAL)

Full Information

First Posted
April 23, 2019
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03927079
Brief Title
Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage
Acronym
ABBA
Official Title
Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotics, Pneumonia
Keywords
Antibiotics, Pneumonia, broncho-alveolar lavage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
measure of intra-alveolar antibiotic concentration in µg/ml
Intervention Description
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
Intervention Name(s)
broncho-alveolar lavage (BAL)
Intervention Description
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
Intervention Name(s)
blood test to measure plasmatic antibiotic concentration in µg/ml
Intervention Description
included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic
Primary Outcome Measure Information:
Title
pulmonary diffusion level for beta lactamins
Description
pulmonary diffusion level for beta lactamins is determined by ratio between bronchoalveolar concentration and plasmatic concentration of tested antibiotics
Time Frame
on the day of the bronco-alveolar lavage
Secondary Outcome Measure Information:
Title
measure of apyrexia duration in days
Description
measure of apyrexia duration in days
Time Frame
from day of inclusion to 15 days after inclusion
Title
duration in days for regression of the biological inflammatory syndrome
Description
duration in days for regression of the biological inflammatory syndrome (CRP concentration in mg/l divided by 2)
Time Frame
from day of inclusion to 15 days after inclusion
Title
measure of length of hospitalisation
Description
measure of length of hospitalisation in days
Time Frame
from day of inclusion to 15 days after inclusion
Title
Number of deaths at 28-day
Description
28-day mortality will be measured
Time Frame
28 days after inclusion
Title
virus presence in BAL
Description
virus presence will be detected in bronchoalveolar lavage (BAL)
Time Frame
day of bronchoalveolar lavage (BAL)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Andrejak, Pr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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