Pneumonia, Bacterial
Conditions
Brief summary
The purpose of this study was to determine the effect of aerosolized colistin on to ventilated patients with carbapenem-resistant gram negative bacteria pneumonia. We hypothesize that adjunct aerosolized colistin, which achieve high drug concentrations in the airway, would more effectively treat the penumbra.
Detailed description
To treat respiratory infection of patients with mechanical ventilation, greater systemic antibiotic dose is required through the patient's venous injection. In this trial, patients with arbapenem-resistant gram negative bacteria pneumonia (CRGNB)were assigned to adjunct aerosolized colistin delivered by a jet nebulizer or a vibrating mesh nebulizer comparing to or standard intravenous injection by a randomizing protocol. Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between standard care and study drug for their effects on bacteria eradiation, incidence of nephrotoxicity, and oxygenation.
Interventions
DEVICEA pneumatic nebulizer
Inhaled colistimethate sodium generated by a pneumatic nebulizer
DEVICEA vibrating mesh nebulizer
Inhaled colistimethate sodium generated by a vibrating mesh nebulizer
Sponsors
Chang Gung Memorial Hospital
Chang Gung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients received invasive mechanical ventilation \>48 hours * Diagnosed with pneumonia caused by carbapenem resistance gram negative bacteria
Exclusion criteria
* pregnant or lactating women * receiving colistin \> 3 days * recurrent pneumonia caused by carbapenem resistance gram negative bacteria * allergy to colistin or polymyxin B drugs * immunocompromised, defined as neutropenia ANC\<500 cells/ul * HIV positive * received chemotherapy with 3 months * renal function deficiency (creatinine clearance \< 30 ml/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pulmonary infection score | 7-10 days | The clinical pulmonary infection score calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation impairment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator pressure control level | 7-10 days | Ventilator pressure control level setting indirectly indicate lung compliance |
Countries
Taiwan
Outcome results
None listed