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There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.
Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colistimethate sodium inhalation | Colistimethate sodium inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria. Additional intravenous colistimethate sodium for patients with ventilator-associated pneumonia | ||
| saline inhalation | saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| clinical cure rate | including clinical improvement and microbiological outcome(eradication of the pathogen as no growth of the pathogen in the final culture of specimens during the entire hospitalization) | From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| intensive care unit stay | From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months | |
| hospital stay | From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in medical intensive care unit with ventilator use
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| Name | Affiliation | Role |
|---|---|---|
| Wang-Huei Sheng, M.D. Ph.D | Center of Infection Control of National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| all cause mortality | From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days |
| ventilator-associated pneumonia-related mortality | Death that occurred during the colistimethate sodium treatment period when the signs of pneumonia remained and as death due to septic shock, assessed up to 28 days |
| microbiologic eradication in colonization patients | From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days |
| ventilator-associated pneumonia rate | From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |