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The purpose of this study is to determine the cure rate from ventilator-associated pneumonia (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to intravenous antibiotics compared to intravenous antibiotics alone.
After inclusion, the patients are randomized into two groups: nebulized amikacin plus intravenous antibiotic(s) or nebulized placebo plus intravenous antibiotic(s). The dose of nebulized amikacin is 400 mg every 12 hours for 10 days. The patients are followed up on day 3, 7, 10, and 28 for safety and efficacy. The estimate sample size is 84 subjects base on previous study of cure rate in VAP and the authors expected that nebulized amikacin can improve cure rate in VAP subjects for 30% when compared with intravenous antibiotic(s) alone with power of 80% at level of significance 0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized amikacin | Experimental | Amikacin 400 mg nebulized every 12 hours plus intravenous antibiotic(s) for 10 days |
|
| placebo | Placebo Comparator | nebulized placebo every 12 hours plus intravenous antibiotic(s)for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amikacin | Drug | 400 mg, nebulizer, every 12 hours, 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| cure rate | Cure rate = improvement/ no new infiltration of chest radiography plus 2/3 of the following: 1) No fever within 48 hours after end of the intervention 2) The reduction of secretion 3) The reduction of white blood cell | 10 days after end of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The reduction of pathogens | quantitative sputum cultures were measured every days for 10 days or no growth of organism. | 10 days after end of the intervention |
| mortality rate | All causes of death during the intervention |
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Inclusion Criteria:
Age >/= 18 years
On mechanical ventilator more than 7 days
VAP diagnosis inclusion criteria:
Evidence of gram negative bacilli from sputum gram stain or previous sputum culture within 1 week
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pitchayapa Ruchiwit, MD | Thammasat University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University (Rangsit center) | Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19698010 | Result | Czosnowski QA, Wood GC, Magnotti LJ, Croce MA, Swanson JM, Boucher BA, Fabian TC. Adjunctive aerosolized antibiotics for treatment of ventilator-associated pneumonia. Pharmacotherapy. 2009 Sep;29(9):1054-60. doi: 10.1592/phco.29.9.1054. | |
| 18752007 | Result | Ghannam DE, Rodriguez GH, Raad II, Safdar A. Inhaled aminoglycosides in cancer patients with ventilator-associated Gram-negative bacterial pneumonia: safety and feasibility in the era of escalating drug resistance. Eur J Clin Microbiol Infect Dis. 2009 Mar;28(3):253-9. doi: 10.1007/s10096-008-0620-5. Epub 2008 Aug 28. |
| Label | URL |
|---|---|
| Adjunctive aerosolized antibiotics for treatment of ventilator-associated pneumonia | View source |
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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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| ID | Term |
|---|---|
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Placebo | Drug | placebo 4 ml, nebulizer, every 12 hours, 10 days |
|
| at 28 days after end of the intervention |
| duration of mechanical ventilation | number of days on mechanical ventilation | at 28 days after end of the intervention |
| duration of ICU stay | number of ICU days | at 28 days after end of the intervention |
| duration of hospitalization | number of days hospitalization | at 28 days after end of the intervention |
| Safety of intervention drug | Any adverse events were recorded | at 28 days after end of the intervention |
| Inhaled aminoglycosides in cancer patients with ventilator-associated Gram-negative bacterial pneumonia: safety and feasibility in the era of escalating drug resistance | View source |
| 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 |