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NCT Number: NCT03927079

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

measure of intra-alveolar antibiotic concentration in µg/ml

Biological

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

broncho-alveolar lavage (BAL)

Procedure

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

blood test to measure plasmatic antibiotic concentration in µg/ml

Biological

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

Primary outcomes

  1. pulmonary diffusion level for beta lactamins

    Time frame: 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 outcomes

  1. measure of apyrexia duration in days

    Time frame: from day of inclusion to 15 days after inclusion

    measure of apyrexia duration in days

  2. duration in days for regression of the biological inflammatory syndrome

    Time frame: 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)

  3. measure of length of hospitalisation

    Time frame: from day of inclusion to 15 days after inclusion

    measure of length of hospitalisation in days

  4. Number of deaths at 28-day

    Time frame: 28 days after inclusion

    28-day mortality will be measured

  5. virus presence in BAL

    Time frame: day of bronchoalveolar lavage (BAL)

    virus presence will be detected in bronchoalveolar lavage (BAL)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ABBA

Important dates

Study start
2019
Primary completion
2022
Study completion
2026
First posted
Apr 25, 2019
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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