Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thammasat University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- cure rate
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age \>/= 18 years
- •On mechanical ventilator more than 7 days
- •VAP diagnosis inclusion criteria:
- •new/progressive infiltration of chest radiography
- •2/3 of the following: 1) fever 2) purulent sputum 3) Wbc \> 12,000 cell/mm3 or \< 4,000 cell/mm3
- •Evidence of gram negative bacilli from sputum gram stain or previous sputum culture within 1 week
Exclusion Criteria
- •History of amikacin allergy
- •GFR \< 30 mL/min except dialytic patients
- •Immunocompromised host: HIV CD4 \< 200 cells/mm3, leukemia, lymphoma, received chemotherapy within 3 weeks, Absolute neutrophil count \< 500/mm3
- •Severe ARDS (P/F ratio \< 100)
- •Endobronchial obstruction:endobronchial mass, endobronchial stenosis
- •Atelectasis
- •Severe bronchospasm
- •Lung abscess
- •Complicated parapneumonic effusion/ Empyema
- •Chest trauma
Arms & Interventions
placebo
nebulized placebo every 12 hours plus intravenous antibiotic(s)for 10 days.
Intervention: Placebo (Drug)
Nebulized amikacin
Amikacin 400 mg nebulized every 12 hours plus intravenous antibiotic(s) for 10 days
Intervention: Amikacin (Drug)
Outcomes
Primary Outcomes
cure rate
Time Frame: 10 days after end of the intervention
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
Secondary Outcomes
- duration of mechanical ventilation(at 28 days after end of the intervention)
- duration of ICU stay(at 28 days after end of the intervention)
- The reduction of pathogens(10 days after end of the intervention)
- mortality rate(at 28 days after end of the intervention)
- duration of hospitalization(at 28 days after end of the intervention)
- Safety of intervention drug(at 28 days after end of the intervention)
Investigators
Pitchayapa Ruchiwit
Principal investigator
Thammasat University