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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03927079
Acronym
ABBA
Enrollment
101
Registered
2019-04-25
Start date
2019-04-23
Completion date
2026-06-01
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotics, Pneumonia

Keywords

Antibiotics, Pneumonia, broncho-alveolar lavage

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.

Interventions

BIOLOGICALmeasure 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

PROCEDUREbroncho-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

BIOLOGICALblood 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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pulmonary diffusion level for beta lactaminson the day of the bronco-alveolar lavagepulmonary diffusion level for beta lactamins is determined by ratio between bronchoalveolar concentration and plasmatic concentration of tested antibiotics

Secondary

MeasureTime frameDescription
measure of apyrexia duration in daysfrom day of inclusion to 15 days after inclusionmeasure of apyrexia duration in days
duration in days for regression of the biological inflammatory syndromefrom day of inclusion to 15 days after inclusionduration in days for regression of the biological inflammatory syndrome (CRP concentration in mg/l divided by 2)
measure of length of hospitalisationfrom day of inclusion to 15 days after inclusionmeasure of length of hospitalisation in days
Number of deaths at 28-day28 days after inclusion28-day mortality will be measured
virus presence in BALday of bronchoalveolar lavage (BAL)virus presence will be detected in bronchoalveolar lavage (BAL)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026