AntibioticsABBANCT03927079
Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage
A study testing measure of intra-alveolar antibiotic concentration in µg/ml, broncho-alveolar lavage (BAL) and blood test to measure plasmatic antibiotic concentration in µg/ml in people with Antibiotics and Pneumonia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotics, Pneumonia
- What is being tested?
- measure of intra-alveolar antibiotic concentration in µg/ml, broncho-alveolar lavage (BAL) and blood test to measure plasmatic antibiotic concentration in µg/ml
- Type of treatment
- Surgery or procedure
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2019to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patient under chronic dialysis
- patient placed under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Antibiotics, Pneumonia
- Being tested
- measure of intra-alveolar antibiotic concentration in µg/ml, broncho-alveolar lavage (BAL), blood test to measure plasmatic antibiotic concentration in µg/ml
- Keywords
- Antibiotics, Pneumonia, broncho-alveolar lavage
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure of intra-alveolar antibiotic concentration in µg/mlBiological
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 or surgery
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/mlBiological
included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: on the day of the bronco-alveolar lavage
Secondary outcomes (5)
measure of apyrexia duration in days
measure of apyrexia duration in days
Measured: 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)
Measured: from day of inclusion to 15 days after inclusion
measure of length of hospitalisation
measure of length of hospitalisation in days
Measured: from day of inclusion to 15 days after inclusion
Number of deaths at 28-day
28-day mortality will be measured
Measured: 28 days after inclusion
virus presence in BAL
virus presence will be detected in bronchoalveolar lavage (BAL)
Measured: day of bronchoalveolar lavage (BAL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start23 Apr 2019
- Primary completion1 Apr 2022
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntibioticsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Andrejak, Pr, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927079
- Sponsor's protocol ID
- PI2018_843_0032
- Acronym
- ABBA
- Status last verified
- Nov 2025
- First submitted
- 23 Apr 2019
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage
- ClinicalTrials.gov ID
- NCT03927079
- Acronym / sponsor ID
- ABBA / PI2018_843_0032
- Conditions
- Antibiotics, Pneumonia
- Keywords
- Antibiotics, Pneumonia, broncho-alveolar lavage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patient under chronic dialysis
- patient placed under judicial protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure of intra-alveolar antibiotic concentration in µg/mlincluded patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration | Biological | – |
| 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 | Procedure or surgery | – |
| blood test to measure plasmatic antibiotic concentration in µg/mlincluded patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic | Biological | – |
Primary outcome
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
5 secondary outcomes
measure of apyrexia duration in days
Time frame: from day of inclusion to 15 days after inclusion
duration in days for regression of the biological inflammatory syndrome
Time frame: from day of inclusion to 15 days after inclusion
measure of length of hospitalisation
Time frame: from day of inclusion to 15 days after inclusion
Number of deaths at 28-day
Time frame: 28 days after inclusion
virus presence in BAL
Time frame: day of bronchoalveolar lavage (BAL)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Andrejak, Pr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measure of intra-alveolar antibiotic concentration in µg/ml, broncho-alveolar lavage (BAL) and blood test to measure plasmatic antibiotic concentration in µg/ml in people with Antibiotics and Pneumonia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary diffusion level for beta lactamins (time frame: on the day of the bronco-alveolar lavage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.