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

NCT02574130 | Completed DMC

• 1 other identifier: MTU-EC-IM-2-046/57
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Ventilator-Associated

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The reduction of pathogens

  10 days after end of the intervention

• mortality rate

  at 28 days after end of the intervention

• duration of mechanical ventilation

  at 28 days after end of the intervention

• duration of ICU stay

  at 28 days after end of the intervention

• duration of hospitalization

  at 28 days after end of the intervention

Study Arms (2)

Nebulized amikacin

EXPERIMENTAL

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

Drug: Amikacin

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Amikacin DRUG

400 mg, nebulizer, every 12 hours, 10 days

Also known as: Amikin

Nebulized amikacin

Placebo DRUG

placebo 4 ml, nebulizer, every 12 hours, 10 days

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 18 years
• On mechanical ventilator more than 7 days
• new/progressive infiltration of chest radiography
• /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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University (Rangsit center)

Pathum Thani, 12120, Thailand

Location

Related 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.

  PMID: 19698010 RESULT

• 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.

  PMID: 18752007 RESULT

Related 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

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Amikacin

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Pitchayapa Ruchiwit, MD

  Thammasat University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 12, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

TH (1)