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A prospective phase IIA multicenter double-blinded randomized placebo-controlled clinical trial evaluating the efficacy and safety of inhaled Tobramycin in patients with ventilator-associated pneumonia (iToVAP) - 21/09/23

Doi : 10.1016/j.accpm.2023.101249 
Stefan Angermair a, , Maria Deja b, Anja Thronicke c, Claudia Grehn d, Nilufar Akbari e, Alexander Uhrig f, Golschan Asgarpur a, Claudia Spies g, Sascha Treskatsch a, Carsten Schwarz h
a Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Berlin, Germany 
b Department of Anesthesiology and Intensive Care Medicine, University of Schleswig-Holstein, Lübeck, Germany 
c Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute for Social Medicine, Epidemiology and Health Economics, Charitéplatz 1, 10117 Berlin, Germany 
d Berlin Institute of Health (BIH), Berlin, Germany 
e Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, 10117 Berlin, Germany 
f Department of Infectious Diseases and Respiratory Medicine, Charité, Universitätsmedizin Berlin, Berlin, Germany 
g Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Anesthesiology and Intensive Care Medicine, Campus Virchow, Berlin, Germany 
h HMU-Health and Medical University, Klinikum Westbrandenburg Potsdam und Charite - Universitätsmedizin Berlin, Germany 

Corresponding author at: Charité – Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.Charité – Campus Benjamin FranklinHindenburgdamm 30Berlin12203Germany

Abstract

Objective

Treatment of ventilated pneumonia is often unsuccessful, even when patients are treated according to current guidelines. Therefore, we aimed to investigate the efficacy of the adjunctive inhaled Tobramycin in patients with pneumonia caused by Gram-negative pathogens in addition to the standard systemic treatment.

Design

Prospective, multicenter, double-blinded, randomized, placebo-controlled clinical trial.

Setting

26 patients in medical and surgical ICUs.

Patients

Patients with ventilator-associated pneumonia caused by Gram-negative pathogens.

Measurement and main results

Fourteen patients were assigned to the Tobramycin Inhal group and 12 patients to the control group. The microbiological eradication of the Gram-negative pathogens was significantly higher in the intervention group than in the control group (p < 0.001). The probability of eradication was 100% in the intervention group [95% Confidence Interval: 0.78–1.0] and 25% in the control group [95% CI: 0.09–0.53]. The increased eradication frequency was not associated with increased patient survival.

Conclusion

Inhaled aerosolized Tobramycin demonstrated clinically meaningful efficacy in patients with Gram-negative ventilator-associated pneumonia. The probability of eradication in the intervention group was 100%. However, the successful eradication was not associated with a reduction in systemic anti-infective therapy, a shorter ICU stay, or even a survival benefit. In the presence of multidrug-resistant Gram-negative pathogens that are sensitive only to colistin and/or aminoglycosides, supplemental inhaled therapy with nebulizers suitable for this purpose should be considered in addition to systemic antibiotic therapy.

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Keywords : Ventilator-associated pneumonia, Intensive care medicine, Critically ill patients, Inhaled aerosolized Tobramycin, Eradication of Gram-negative pathogen


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Vol 42 - N° 5

Articolo 101249- Ottobre 2023 Ritorno al numero
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