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

Not Applicable

Completed

• Conditions: Pneumonia, Ventilator-Associated
• Interventions: Drug: Placebo; Drug: Amikacin

• Registration Number: NCT02574130
• Lead Sponsor: Thammasat University

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age >/= 18 years

• On mechanical ventilator more than 7 days

• VAP diagnosis inclusion criteria:

  1. new/progressive infiltration of chest radiography
  2. 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
• Uncontrolled extrapulmonary infection(s)
• Received intravenous antibiotic(s) more than 48 hours
• Pregnancy/ Lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	nebulized placebo every 12 hours plus intravenous antibiotic(s)for 10 days.
Nebulized amikacin	Amikacin	Amikacin 400 mg nebulized every 12 hours plus intravenous antibiotic(s) for 10 days

Primary Outcome Measures

Name	Time	Method
cure rate	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 Outcome Measures

Name	Time	Method
duration of mechanical ventilation	at 28 days after end of the intervention	number of days on mechanical ventilation
duration of ICU stay	at 28 days after end of the intervention	number of ICU days
The reduction of pathogens	10 days after end of the intervention	quantitative sputum cultures were measured every days for 10 days or no growth of organism.
mortality rate	at 28 days after end of the intervention	All causes of death during the intervention
duration of hospitalization	at 28 days after end of the intervention	number of days hospitalization
Safety of intervention drug	at 28 days after end of the intervention	Any adverse events were recorded

Trial Locations

Locations (1)

Thammasat University (Rangsit center); 🇹🇭 Pathumthani, Thailand