The mortality of pneumonia with extensively drug resistant Acinetobacter baumannii (XDRAB) is still high, even if these patients received certain strong anti-infection treatment such us the combination of cefoperazone-sulbactam (C/S) and minocycline. Health airway lining fluid is mildly alkaline but airway acidification usually appears for the infection of XDRAB. The hypothesis is offered that the biologic activity of XDRAB might be inhibited if the circumstance including pH is changed. In the vitro study we observed that the inhibit effect of antibiotics on XDRAB growth was improved significantly by alkaline solution within the scope of physiology. So the aim of this clinical study is to explore the effects of nebulization of alkaline Solution on C/S plus minocycline on the pneumonia with XDRAB.
Pneumonia patients with XDRAB are eligible for this multicenter study, do not meet the exclusion criteria and will sign the informed consent. They will received the anti-infection protocol with Cefoperazone/ sulbactam 3.0g(intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h). All enrolled patients were randomly divided into three groups according to the difference in pH value of aerosol inhalation with sodium bicarbonate solution. Group one is blank-control and patients will received usual antibiotic treatment without inhalation. The pH value in group two is 7.4 and that in group is 7.8. Each time the volume of aerosol solution is 5ml, q8h. The average course of treatment will be two weeks. Clinical indexes will be collected including vital signs, pulmonary rales, cough level, expectoration level, sputum color,blood count, arterial blood gas, biochemical parameters, chest X-ray score, APACHE II score, clinical pulmonary infection score, ECG, sputum culture, et al.The primary endpoints are pathogenic clearance rate and recovery rate. The secondary end point is adverse reaction rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Cefoperazone/ sulbactam 3.0g(intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h).
Patients will receive the nebulization with Sodium Bicarbonate of pH 7.4 (Each time the volume of aerosol solution is 5ml, q8h).
Patients will receive the nebulization with Sodium Bicarbonate of pH 7.8 (Each time the volume of aerosol solution is 5ml, q8h).
No nebulization will be given to the patients.
Xijing Hospital
Xi'an, Shaanxi, China
Pathogenic Clearance rate and recovery rate
Time frame: one treatment course for about two weeks
adverse reaction rate
Time frame: one treatment course for about two weeks
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