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

Thammasat University

Status: Completed

Conditions: Pneumonia, Ventilator-Associated

Treatments: Drug: Placebo; Drug: Amikacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02574130

MTU-EC-IM-2-046/57

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Nebulized amikacin

Experimental group

Description:

Amikacin 400 mg nebulized every 12 hours plus intravenous antibiotic(s) for 10 days

Treatment:

Drug: Amikacin

placebo

Placebo Comparator group

Description:

nebulized placebo every 12 hours plus intravenous antibiotic(s)for 10 days.

Treatment:

Drug: Placebo