Pneumonia, Ventilator-AssociatedNCT02574130
Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria
A study testing Amikacin in people with Pneumonia, Ventilator-Associated, run by Thammasat University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Amikacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- On mechanical ventilator more than 7 days
- VAP diagnosis inclusion criteria:
- new/progressive infiltration of chest radiography
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Amikacin, Placebo
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinDrug
Also called Amikin
400 mg, nebulizer, every 12 hours, 10 days
PlaceboDrug
placebo 4 ml, nebulizer, every 12 hours, 10 days
| Study group | Role | What they receive |
|---|---|---|
| Nebulized amikacin | Experimental | Amikacin 400 mg nebulized every 12 hours plus intravenous antibiotic(s) for 10 days Receives: Drug: Amikacin |
| placebo | Placebo comparator | nebulized placebo every 12 hours plus intravenous antibiotic(s)for 10 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days after end of the intervention
Secondary outcomes (6)
The reduction of pathogens
quantitative sputum cultures were measured every days for 10 days or no growth of organism.
Measured: 10 days after end of the intervention
mortality rate
All causes of death during the intervention
Measured: at 28 days after end of the intervention
duration of mechanical ventilation
number of days on mechanical ventilation
Measured: at 28 days after end of the intervention
duration of ICU stay
number of ICU days
Measured: at 28 days after end of the intervention
duration of hospitalization
number of days hospitalization
Measured: at 28 days after end of the intervention
Safety of intervention drug
Any adverse events were recorded
Measured: at 28 days after end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pitchayapa Ruchiwit, Thammasat University
- Investigators
- Pitchayapa Ruchiwit, MD, Principal investigator, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574130
- Sponsor's protocol ID
- MTU-EC-IM-2-046/57
- Status last verified
- Apr 2018
- First submitted
- 9 Oct 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19698010Ghannam 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.
PubMed 18752007
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria
- ClinicalTrials.gov ID
- NCT02574130
- Acronym / sponsor ID
- MTU-EC-IM-2-046/57
- Conditions
- Pneumonia, Ventilator-Associated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized amikacin | Experimental | Drug: AmikacinAmikacin 400 mg nebulized every 12 hours plus intravenous antibiotic(s) for 10 days |
| placebo | Placebo comparator | Drug: Placebonebulized placebo every 12 hours plus intravenous antibiotic(s)for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >/= 18 years
- On mechanical ventilator more than 7 days
- VAP diagnosis inclusion criteria:
- Evidence of gram negative bacilli from sputum gram stain or previous sputum culture within 1 week
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmikacinAlso: Amikin400 mg, nebulizer, every 12 hours, 10 days | Drug | Nebulized amikacin |
| Placeboplacebo 4 ml, nebulizer, every 12 hours, 10 days | Drug | placebo |
Primary outcome
cure rate
Time frame: 10 days after end of the intervention
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
6 secondary outcomes
The reduction of pathogens
Time frame: 10 days after end of the intervention
mortality rate
Time frame: at 28 days after end of the intervention
duration of mechanical ventilation
Time frame: at 28 days after end of the intervention
duration of ICU stay
Time frame: at 28 days after end of the intervention
duration of hospitalization
Time frame: at 28 days after end of the intervention
Safety of intervention drug
Time frame: at 28 days after end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Results publication: PubMed 19698010Czosnowski 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.
- Results publication: PubMed 18752007Ghannam 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.
- Adjunctive aerosolized antibiotics for treatment of ventilator-associated pneumoniaLink provided by the sponsor.
- Inhaled aminoglycosides in cancer patients with ventilator-associated Gram-negative bacterial pneumonia: safety and feasibility in the era of escalating drug resistanceLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pitchayapa Ruchiwit, MD principal investigator
Thammasat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amikacin in people with Pneumonia, Ventilator-Associated, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: 10 days after end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574130, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.