Nebulized Amikacine for Ventilator associated gram negative Pneumonia in ECMO veno-arterial patients: A randomized Pilot Study (NAVAP-ECMO)

Conditions

gram-negative bacillus pneumonia acquired during mechanical ventilation in patients receiving Extracorporeal Membrane veno-arterial oxygenation

Brief summary

Bacterial eradication rate, defined as absence of germs on direct examination and negative culture of a tracheal aspirate taken on day 5 (D5) after randomisation and at least 12 hours after the last administration of inhaled amikacin

Detailed description

Clinical cure rate, defined as the disappearance of clinical signs suggestive of pneumonia, biological inflammatory syndrome, and correction of haematosis disorders, at D5, Pneumonia persistence rate defined as the presence of the pathogen identified at a significant level on culture of tracheal aspirate at D5, Difference between CPIS score at D5 and CPIS score at randomization, Difference between ultrasound lung ventilation score at D5 and lung ventilation score at randomization, Quantifying and analysing adverse events, Pharmacokinetic analysis of plasma concentrations of piperacillin-tazobactam, Measurement of the ratio of penetration into alveolar fluid (AUC alveolar fluid/AUC plasma) of piperacillin-tazobactam in patients undergoing VA-ECMO after 2 days of intravenous antibiotic therapy

Related papers

No related papers found yet.

Interventions

DRUGPIPERACILLIN AND BETA-LACTAMASE INHIBITOR

DRUGAMIKACIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Bacterial eradication rate, defined as absence of germs on direct examination and negative culture of a tracheal aspirate taken on day 5 (D5) after randomisation and at least 12 hours after the last administration of inhaled amikacin	—

Secondary

Measure	Time frame
Clinical cure rate, defined as the disappearance of clinical signs suggestive of pneumonia, biological inflammatory syndrome, and correction of haematosis disorders, at D5, Pneumonia persistence rate defined as the presence of the pathogen identified at a significant level on culture of tracheal aspirate at D5, Difference between CPIS score at D5 and CPIS score at randomization, Difference between ultrasound lung ventilation score at D5 and lung ventilation score at randomization, Quantifying and analysing adverse events, Pharmacokinetic analysis of plasma concentrations of piperacillin-tazobactam, Measurement of the ratio of penetration into alveolar fluid (AUC alveolar fluid/AUC plasma) of piperacillin-tazobactam in patients undergoing VA-ECMO after 2 days of intravenous antibiotic therapy	—

Measure

Time frame

Clinical cure rate, defined as the disappearance of clinical signs suggestive of pneumonia, biological inflammatory syndrome, and correction of haematosis disorders, at D5, Pneumonia persistence rate defined as the presence of the pathogen identified at a significant level on culture of tracheal aspirate at D5, Difference between CPIS score at D5 and CPIS score at randomization, Difference between ultrasound lung ventilation score at D5 and lung ventilation score at randomization, Quantifying and analysing adverse events, Pharmacokinetic analysis of plasma concentrations of piperacillin-tazobactam, Measurement of the ratio of penetration into alveolar fluid (AUC alveolar fluid/AUC plasma) of piperacillin-tazobactam in patients undergoing VA-ECMO after 2 days of intravenous antibiotic therapy

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Countries

France

Outcome results

None listed