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

Primary Purpose

Pneumonia, Ventilator-Associated

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Amikacin

Placebo

About this trial

This is an interventional treatment trial for Pneumonia, Ventilator-Associated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Thammasat University (Rangsit center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nebulized amikacin

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The reduction of pathogens

quantitative sputum cultures were measured every days for 10 days or no growth of organism.

mortality rate

All causes of death during the intervention

duration of mechanical ventilation

number of days on mechanical ventilation

duration of ICU stay

number of ICU days

duration of hospitalization

number of days hospitalization

Safety of intervention drug

Any adverse events were recorded

Full Information

NCT ID

NCT02574130

First Posted

October 9, 2015

Last Updated

April 24, 2018

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT02574130

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Ventilator-Associated

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nebulized amikacin

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Amikacin

Other Intervention Name(s)

Amikin

Intervention Description

400 mg, nebulizer, every 12 hours, 10 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

cure rate

Description

Time Frame

10 days after end of the intervention

Secondary Outcome Measure Information:

Title

The reduction of pathogens

Description

quantitative sputum cultures were measured every days for 10 days or no growth of organism.

Time Frame

10 days after end of the intervention

Title

mortality rate

Description

All causes of death during the intervention

Time Frame