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

Pneumonia, Ventilator-Associated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574130
• Other study ID #: MTU-EC-IM-2-046/57
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: April 24, 2018
• Start date: July 2015
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Ventilator-Associated

Intervention

Drug:
• Amikacin
400 mg, nebulizer, every 12 hours, 10 days
• Placebo
placebo 4 ml, nebulizer, every 12 hours, 10 days

Locations

Country	Name	City	State
Thailand	Thammasat University (Rangsit center)	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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. — View 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 Ma — View Citation

Outcome

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

External Links

•   Adjunctive aerosolized antibiotics for treatment of ventilator-associated pneumonia
•   Inhaled aminoglycosides in cancer patients with ventilator-associated Gram-negative bacterial pneumonia: safety and feasibility in the era of escalating drug resistance