Clinical trial NCT02574130: Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria
Official title: Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Ventilator-Associated
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cure rate
timeFrame: 10 days after end of the intervention
Secondary outcomes:
measure: The reduction of pathogens
timeFrame: 10 days after end of the intervention
measure: mortality rate
timeFrame: at 28 days after end of the intervention
measure: duration of mechanical ventilation
timeFrame: at 28 days after end of the intervention
measure: duration of ICU stay
timeFrame: at 28 days after end of the intervention
measure: duration of hospitalization
timeFrame: at 28 days after end of the intervention
measure: Safety of intervention drug
timeFrame: at 28 days after end of the intervention
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat University (Rangsit center)
Study officials:
affiliation: Thammasat University Hospital
name: Pitchayapa Ruchiwit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.