Clinical Outcomes of Adjunct Nebulized Colistin by 2 Types of Nebulizers and Cost-Effectiveness Analysis

The incidences of multiple drug resistant bacteria are in the raise. Colistin are employed to treat multiple drug resistant gram negative bacteria. With intravenous inject, the adverse effects associated with nephrotocixity and ototocixity occur up to 50 % of patients. To treat pneumonia, research has been employ colistin with nebulized inhalation. Clinical trials indicated that the inhaled colistin results similar clinical outcomes than with the injection route, yet with less nephrotocixity. The joint consensus of guideline recommended that nebulized colistin should be part of regimen in management of ventilator-associated pneumonia. Jet nebulizer is the most commonly used device with only 5-10% of total dose delivery through ventilation; in contrast, vibrating mesh nebulizer delivers 40 % of dose, becoming popular in the clinical trials. Yet the vibrating mesh nebulizer is costly, not commonly used in Taiwan. The administration of antibiotics tends to given with the minimum dose, in contrast to deliver higher dose by efficient nebulizers. The use of delivery higher inhaled dose with an expensive device remains controversial. In this randomized clinical trial, we aimed to evaluate the clinical outcomes of bacteria eradiation, incidence of nephrotoxicity, and oxygenation treated with adjunct nebulized colistin to ventilated-associated pneumonia patients caused by carbapenem-resistant gram negative bacteria. We will enroll 40 patients in each of three groups for a total of 120, as randomized into each of following group (1) the control group will receive standard colistin dose through intravenous inject; (2) the second group will receive adjunct inhaled colistin generate by a vibrating mesh nebulize; and (3) the third group will receive adjunct inhaled colistin generate by a jet nebulizer. The objectives of this study was to evaluate the outcomes of adjunct inhaled colistin therapy generated by different nebulizers on the following parameters: (1) the improvement of pulmonary infection, including bacteria eradiation time, clinical pulmonary infection score, C-reactive protein, and procalcitonin; (2) ventilator settings, such as pressure control level, PaO2/FiO2 ratio, and ventilator days; (3) clinical outcomes, including ICU days, hospitalization days, 30-day mortality, and 90-day motality; and (4) incidences of adverse effects. In addition to the clinical outcomes, we will also conduct cost-effectiveness analyses. We will recommend a Taiwanese version of optimal nebulized colistin deliver method on patients with pneumonia base on cost-effectiveness for improvement of clinical outcomes, reducing the adverse effects, and enhancing the cure rate, improving of quality of critical care, and reduction of medical expenditure. For the final results of the study, we aim to publish in two articles on the clinical outcomes of the adjunct nebulized colistin and the cost-effectiveness of treating pneumonia with adjunct colistin therapy in the field of pharmacology and crtical care.

Project ID:PC10907-1139
External Project ID:MOST109-2314-B182-067