NCT02574130

Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Thammasat University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pneumonia, Ventilator-Associated

Interventions

Type	Name	Description
DRUG	Amikacin	400 mg, nebulizer, every 12 hours, 10 days
DRUG	Placebo	placebo 4 ml, nebulizer, every 12 hours, 10 days

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2015-10-12
• Last updated: 2018-04-26

Locations

1 site across 1 country: Thailand