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

NCT03927079 | Active Not Recruiting

• 1 other identifier: PI2018_843_0032
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotics; Pneumonia

Keywords

Antibiotics; Pneumonia; broncho-alveolar lavage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• measure of apyrexia duration in days

  from day of inclusion to 15 days after inclusion

• duration in days for regression of the biological inflammatory syndrome

  from day of inclusion to 15 days after inclusion

• measure of length of hospitalisation

  from day of inclusion to 15 days after inclusion

• Number of deaths at 28-day

  28 days after inclusion

• virus presence in BAL

  day of bronchoalveolar lavage (BAL)

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patient under chronic dialysis
• patient placed under judicial protection

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Claire Andrejak, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: April 23, 2019
• Primary Completion: April 1, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)