PneumoniaPhase 2NCT01021436
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
A Phase 2 study testing Amikacin inhalation solution (BAY41-6551) in people with Pneumonia, run by Bayer at 6 sites in 2 countries.
Trial summary
This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated 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 inhalation solution (BAY41-6551)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2007to Aug 2007
- 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 or female subjects with confirmed pneumonia, defined as the presence of a new progressive infiltrate(s) on chest radiograph and the presence of gram-negative organism by either culture or Gram stain of respiratory secretions. The subject must be intubated and mechanically ventilated and expected to remain so for at least 3 days after the start of study treatment. Subjects with a tracheostomy were also eligible.
Who cannot join
- Subjects with compromised or suppressed Immune systems, severe hypoxemia, neutropenia, serum creatinine > 2mg/dl and chronic liver disease
- Had primary lung cancer or another malignancy metastatic to the lungs
- Were known or suspected to have active tuberculosis, cystic fibrosis, acquired immunodeficiency syndrome, or Pneumocystis carinii pneumonia
- Were receiving immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
- Had a body mass index of ≥30 kg/m2
- Had burns >40% of total body surface area
Show all 12Show fewer
- Had known local or systemic hypersensitivity to amikacin or aminoglycosides
- Had a diagnosis of end-stage renal failure or were currently on dialysis treatment
- Had a serum albumin level <2 g/dL at Screening
- Used amikacin by any route within 7 days before the start of study treatment
- Had a presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and Follow-Up could be completed
- Had known respiratory colonization with amikacin-resistant gram-negative rods
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Study site
Birminghan, Alabama, 35233
Study site
Cincinnati, Ohio, 45267
Study site
Houston, Texas, 77030
Study site
Memphis, Tennessee, 38163
France2 sites
Study site
Limoges, Cedex, 87046
Study site
Paris, Cedex 13, 75651
About this study
Official title: An Open-Label, Multicenter, Multinational Study to Assess the Safety,Tolerability and Pharmacokinetics of Aerosolized Amikacin Delivered Via the Pulmonary Drug Delivery System (NKTR-061) in Intubated and Mechanically- Ventilated Patients With Nosocomial Pneumonia
This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated
- Conditions
- Pneumonia
- Being tested
- Amikacin inhalation solution (BAY41-6551)
- Keywords
- Pneumonia, 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 inhalation solution (BAY41-6551)Drug
Daily dose of 800 mg of aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment 12 hour
| Study group | Role | What they receive |
|---|---|---|
| Amikacin inhalation solution | Experimental | Subjects received 125 mg/mL of aerosolized amikacin via the PDDS clinical device at a nominal dose of 400 mg every 12 h for 7-14 days Receives: Drug: Amikacin inhalation solution (BAY41-6551) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum serum amikacin concentration observed from time 0 to 12 h
Measured: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose
Tmax
Time that Cmax occurred
Measured: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose
AUC0-12h
Area under the serum amikacin concentration vs time curve from time 0 to 12 h
Measured: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose
Xu0-12h
Amount of amikacin excreted in urine from 0 to 12 h after dosing
Measured: On Day 3 at the start of dose and up to 12 h after both first and second dose
Xu12-24h
Amount of amikacin excreted in urine from 12 to 24 h after dosing
Measured: On Day 3 at the start of dose and up to 12 h after both first and second dose
Xu0-24h
Amount of amikacin excreted in urine from 0 to 24 h after dosing
Measured: On Day 3 at the start of dose and up to 12 h after both first and second dose
Tracheal aspirate
Measured: Day 3
Epithelial lining fluid (ELF) concentration
Measured: Approximately 15-30 min after completion of the morning dose of study medication on Day 3
Secondary outcomes (1)
Number of participants with adverse events
Measured: Approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startMar 2007
- Primary completionAug 2007
- Study completionAug 2007
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021436
- Sponsor's protocol ID
- 06-IN-AK004
- Other IDs
- 2006-005079-17
- Status last verified
- Feb 2016
- First submitted
- 25 Nov 2009
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Luyt CE, Clavel M, Guntupalli K, Johannigman J, Kennedy JI, Wood C, Corkery K, Gribben D, Chastre J. Pharmacokinetics and lung delivery of PDDS-aerosolized amikacin (NKTR-061) in intubated and mechanically ventilated patients with nosocomial pneumonia. Crit Care. 2009;13(6):R200. doi: 10.1186/cc8206. Epub 2009 Dec 10.
PubMed 20003269
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Multinational Study to Assess the Safety,Tolerability and Pharmacokinetics of Aerosolized Amikacin Delivered Via the Pulmonary Drug Delivery System (NKTR-061) in Intubated and Mechanically- Ventilated Patients With Nosocomial Pneumonia
- ClinicalTrials.gov ID
- NCT01021436
- Acronym / sponsor ID
- 06-IN-AK004
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Gram-negative bacteria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Study start
- Mar 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 30 Nov 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 to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amikacin inhalation solution | Experimental | Drug: Amikacin inhalation solution (BAY41-6551)Subjects received 125 mg/mL of aerosolized amikacin via the PDDS clinical device at a nominal dose of 400 mg every 12 h for 7-14 days |
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 or female subjects with confirmed pneumonia, defined as the presence of a new progressive infiltrate(s) on chest radiograph and the presence of gram-negative organism by either culture or Gram stain of respiratory secretions. The subject must be intubated and mechanically ventilated and expected to remain so for at least 3 days after the start of study treatment. Subjects with a tracheostomy were also eligible.
Key exclusion criteria (12 listed)
- Subjects with compromised or suppressed Immune systems, severe hypoxemia, neutropenia, serum creatinine > 2mg/dl and chronic liver disease
- Had primary lung cancer or another malignancy metastatic to the lungs
- Were known or suspected to have active tuberculosis, cystic fibrosis, acquired immunodeficiency syndrome, or Pneumocystis carinii pneumonia
- Were receiving immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
- Had a body mass index of ≥30 kg/m2
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 inhalation solution (BAY41-6551)Daily dose of 800 mg of aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment 12 hour | Drug | Amikacin inhalation solution |
Primary outcome
Cmax
Time frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose
Maximum serum amikacin concentration observed from time 0 to 12 h
Tmax
Time frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose
Time that Cmax occurred
AUC0-12h
Time frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose
Area under the serum amikacin concentration vs time curve from time 0 to 12 h
Xu0-12h
Time frame: On Day 3 at the start of dose and up to 12 h after both first and second dose
Amount of amikacin excreted in urine from 0 to 12 h after dosing
Xu12-24h
Time frame: On Day 3 at the start of dose and up to 12 h after both first and second dose
Amount of amikacin excreted in urine from 12 to 24 h after dosing
Xu0-24h
Time frame: On Day 3 at the start of dose and up to 12 h after both first and second dose
Amount of amikacin excreted in urine from 0 to 24 h after dosing
Tracheal aspirate
Time frame: Day 3
Epithelial lining fluid (ELF) concentration
Time frame: Approximately 15-30 min after completion of the morning dose of study medication on Day 3
1 secondary outcome
Number of participants with adverse events
Time frame: Approximately 6 weeks
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 18 Feb 2016.
- Results publication: PubMed 20003269Luyt CE, Clavel M, Guntupalli K, Johannigman J, Kennedy JI, Wood C, Corkery K, Gribben D, Chastre J. Pharmacokinetics and lung delivery of PDDS-aerosolized amikacin (NKTR-061) in intubated and mechanically ventilated patients with nosocomial pneumonia. Crit Care. 2009;13(6):R200. doi: 10.1186/cc8206. Epub 2009 Dec 10.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link 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.
Bayer Study Director study director
Bayer
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amikacin inhalation solution (BAY41-6551) in people with Pneumonia, run by Bayer at 6 sites in 2 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 12 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France. 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. 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?
Cmax (time frame: Pre-dose and up to 12 h post-dose after the start of dosing and also at 1 h and 12 h after the administration of the second dose). The study lists 8 primary outcomes in all. 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 NCT01021436, 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 18 Feb 2016.