PneumoniaPhase 2NCT01004445
A Study to Determine the Correct Dose of Amikacin Which is Delivered Directly to the Lungs of Ventilated Patients as an Aerosol Via an Investigational Device Called the Pulmonary Delivery Device System (PDDS)
A Phase 2 study testing Amikacin (BAY41-6551) in people with Pneumonia, run by Bayer at 20 sites in 3 countries.
Trial summary
This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Amikacin (BAY41-6551)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 20 sitesin 3 countries
- Study dates
- May 2005to Jun 2006
- Phase
- Phase 2
- 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
- Male and female patients 18 years of age or older with a clinical diagnosis of VAP, HAP or HCAP who are expected to be on mechanical ventilation for at least 3 days
Who cannot join
- Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States7 sites
Study site
Albany, New York, 12208
Study site
Birmingham, Alabama, 35233
Study site
Columbus, Ohio, 43210
Study site
Houston, Texas, 77030
Study site
Melbourne, Florida, 32901
Study site
San Antonio, Texas, 78229
Study site
Winston-Salem, North Carolina, 27157
France7 sites
Study site
Angers, 49933
Study site
Limoges, 87046
Study site
Paris, 75018
Study site
Paris, 75651
Study site
Paris, 75674
Study site
Paris, 75908
Study site
Rouen, 76031
Spain6 sites
Study site
Barcelona, 08003
Study site
Barcelona, 08036
Study site
Madrid, 28034
Study site
Madrid, 28040
Study site
Madrid, 28805
Study site
Murcia, 30120
About this study
Official title: A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms
This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).
- Conditions
- Pneumonia
- Being tested
- Amikacin (BAY41-6551), Placebo
- Keywords
- Pneumonia, Adjunctive treatment, Gram-negative bacteria
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amikacin (BAY41-6551)Drug
Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule
Amikacin (BAY41-6551)Drug
Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr
PlaceboDrug
Two aerosol treatments per day (one treatment every 12hr)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Amikacin (BAY41-6551) |
| Arm 2 | Experimental | Not described Receives: Drug: Amikacin (BAY41-6551) |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1
Measured: Day 1
Secondary outcomes (8)
Mean C(max) and mean AUC of amikacin in tracheal aspirates
Measured: Day 1 and Day 3 of treatment period
Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC
Measured: Day 1 and Day 3 of treatment period
Clinical cure rate
Measured: Test of cure visit (7 days post last treatment dose)
Microbiological eradication rate of identified pathogens
Measured: Test of cure visit (7 days post last treatment dose)
Microbiological persistence rate
Measured: Test of cure visit (7 days post last treatment dose)
New infection rate
Measured: Test of cure visit (7 days post last treatment dose)
Assessment of adverse events related to drug or device
Measured: Treatment period, early post treatment period, test of cure visit, and late post treatment
Assessment of abnormal laboratory values
Measured: Treatment period, early post treatment period, test of cure visit, and late post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startMay 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004445
- Sponsor's protocol ID
- AMIK-04-02
- Status last verified
- Apr 2011
- First submitted
- 29 Oct 2009
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Niederman MS, Chastre J, Corkery K, Fink JB, Luyt CE, Garcia MS. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med. 2012 Feb;38(2):263-71. doi: 10.1007/s00134-011-2420-0. Epub 2011 Dec 7.
PubMed 22147112
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms
- ClinicalTrials.gov ID
- NCT01004445
- Acronym / sponsor ID
- AMIK-04-02
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Adjunctive treatment, Gram-negative bacteria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Study start
- May 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 30 Oct 2009 (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.
This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Amikacin (BAY41-6551) |
| Arm 2 | Experimental | Drug: Amikacin (BAY41-6551) |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients 18 years of age or older with a clinical diagnosis of VAP, HAP or HCAP who are expected to be on mechanical ventilation for at least 3 days
Key exclusion criteria (1 listed)
- Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant
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 |
|---|---|---|
| Amikacin (BAY41-6551)Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule | Drug | Arm 1 |
| Amikacin (BAY41-6551)Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr | Drug | Arm 2 |
| PlaceboTwo aerosol treatments per day (one treatment every 12hr) | Drug | Arm 3 |
Primary outcome
Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1
Time frame: Day 1
8 secondary outcomes
Mean C(max) and mean AUC of amikacin in tracheal aspirates
Time frame: Day 1 and Day 3 of treatment period
Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC
Time frame: Day 1 and Day 3 of treatment period
Clinical cure rate
Time frame: Test of cure visit (7 days post last treatment dose)
Microbiological eradication rate of identified pathogens
Time frame: Test of cure visit (7 days post last treatment dose)
Microbiological persistence rate
Time frame: Test of cure visit (7 days post last treatment dose)
New infection rate
Time frame: Test of cure visit (7 days post last treatment dose)
Assessment of adverse events related to drug or device
Time frame: Treatment period, early post treatment period, test of cure visit, and late post treatment
Assessment of abnormal laboratory values
Time frame: Treatment period, early post treatment period, test of cure visit, and late post treatment
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 8 Apr 2011.
- Derived from this study: PubMed 22147112Niederman MS, Chastre J, Corkery K, Fink JB, Luyt CE, Garcia MS. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med. 2012 Feb;38(2):263-71. doi: 10.1007/s00134-011-2420-0. Epub 2011 Dec 7.
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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.
Bayer Study Director study director
Bayer
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amikacin (BAY41-6551) in people with Pneumonia, run by Bayer at 20 sites in 3 countries.
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 1 inclusion and 1 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 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, France, Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1 (time frame: Day 1). 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 NCT01004445, which also lists 1 linked publication.
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 8 Apr 2011.