AzTrials
AzTrials

Pneumonia, BacterialPhase 3INHALE 1NCT01799993

Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

A Phase 3 study testing Amikacin Inhalation Solution (BAY41-6551) in people with Pneumonia, Bacterial, run by Bayer at 65 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Bacterial
What is being tested?
Amikacin Inhalation Solution (BAY41-6551)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
725 participants
Where
65 sitesin 12 countries
Study dates
13 Apr 2013to 7 Apr 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Males and non-pregnant, non-lactating females, 18 years of age or older
  • Intubated and mechanically-ventilated
  • Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph
  • Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen
  • Impaired oxygenation
  • Clinical Pulmonary Infection Score (CPIS) of at least 6
  • Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms

Who cannot join

  • History of hypersensitivity to amikacin or other aminoglycosides
  • Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
  • Known or suspected bacteremia secondary to Staphylococcus aureus
  • A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
  • Patients with a serum creatinine > 2 mg/dL (177 µmol/L) [Exception: Patients with a serum creatinine > 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment]
  • Has been on mechanical ventilation for > 28 days
Show all 10Show fewer
  • Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
  • The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
  • Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10
  • Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)

Trial locations and contacts

65 sites in 12 countries.

65 sites in 12 countries

United States32 sites

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Birmingham, Alabama, 35233

  • Study site

    Brooklyn, New York, 11215

  • Study site

    Butte, Montana, 59701

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Cincinnati, Ohio, 45267-0769

  • Study site

    Cleveland, Ohio, 44109-1998

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Danbury, Connecticut, 06810

  • Study site

    Greensboro, North Carolina, 27401

  • Study site

    Hartford, Connecticut, 06102

  • Study site

    Hazard, Kentucky, 41701

  • Study site

    Hollywood, Florida, 33021-5421

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Kalamazoo, Michigan, 49007

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Miami, Florida, 33125

  • Study site

    Mineola, New York, 10065

  • Study site

    Mobile, Alabama, 36617

  • Study site

    Muncie, Indiana, 47303

  • Study site

    New York, New York, 10019

  • Study site

    New York, New York, 10065

  • Study site

    Newark, Delaware, 19713

  • Study site

    Oklahoma City, Oklahoma, 73117

  • Study site

    Phoenix, Arizona, 85008-4956

  • Study site

    Springfield, Illinois, 62702

  • Study site

    Springfield, Missouri, 65803

  • Study site

    St Louis, Missouri, 63110-1093

  • Study site

    Tampa, Florida, 33606-3508

  • Study site

    Youngstown, Ohio, 44501

Other trials in United States

Canada5 sites

  • Study site

    Kingston, Ontario

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Québec, G1V 4G5

  • Study site

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Mexico5 sites

  • Study site

    Aguascalientes, 20000

  • Study site

    Guadalajara, Jalisco, 44340

  • Study site

    México, D.F., Mexico City, 07760

  • Study site

    Monterrey, Nuevo León, 64460

  • Study site

    San Luis Potosí City, 78240

Other trials in Mexico

Taiwan4 sites

  • Study site

    Kaohsiung City, 82445

  • Study site

    Tainan, 710

  • Study site

    Taipei, 11217

  • Study site

    Taipei

Other trials in Taiwan

Australia3 sites

  • Study site

    Blacktown, New South Wales, 2148

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Wollongong, 2500

Other trials in Australia

Brazil3 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150 221

  • Study site

    Campinas, São Paulo, 13060904

  • Study site

    São José do Rio Preto, São Paulo

Other trials in Brazil

South Korea3 sites

  • Study site

    Seoul, 136-705

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 138-736

Other trials in South Korea

Colombia2 sites

  • Study site

    Barranquilla, Atlántico

  • Study site

    Cali, Valle del Cauca Department

Other trials in Colombia

Czechia2 sites

  • Study site

    Prague, 100 34

  • Study site

    Zlín, 762 75

Other trials in Czechia

Philippines2 sites

  • Study site

    Quezon City, 1105

  • Study site

    Quezon City, NCR 1100

Other trials in Philippines

Thailand2 sites

  • Study site

    Chiang Mai, 50200

  • Study site

    Khon Kaen, 40002

Other trials in Thailand

Turkey (Türkiye)2 sites

  • Study site

    Ankara, 06100

  • Study site

    Trabzon, 61080

Other trials in Turkey (Türkiye)

About this study

Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).

Being tested
Amikacin Inhalation Solution (BAY41-6551), Aerosolized Placebo
Keywords
Gram-negative pneumonia, Intubation, Mechanical ventilation, Amikacin
Medical subject headings
Pneumonia, Bacterial

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

    400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)

  • Aerosolized PlaceboDrug

    Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)

Study groups in NCT01799993
Study groupRoleWhat they receive
Amikacin inhale (BAY41-6551)ExperimentalParticipants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.
Receives: Drug: Amikacin Inhalation Solution (BAY41-6551)
PlaceboPlacebo comparatorParticipants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.
Receives: Drug: Aerosolized Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Surviving Through LFU Visit

    The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.

    Measured: Up to 28-32 days after start of study treatment

Secondary outcomes (4)

  1. Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit

    Death through LFU visit was adjudicated as pneumonia-related or pneumonia-unrelated for participants in the amikacin inhale group and participants in the placebo group.

    Measured: Up to 28-32 days after start of study treatment

  2. Number of Participants With Early Clinical Response

    Early Clinical Response was determined by the following: 1. CPIS scoring at Days 3, 5, and 10 compared to baseline (a. On Day 3, CPIS increase from baseline by at least 2 points was considered a failure. b. On Day 5, CPIS decrease from baseline of at least 1 point was not a failure. CPIS of no change from baseline was considered a failure. Any CPIS increase from baseline was a failure. c. On Day 10, CPIS decrease from baseline of at least 2 points was not a failure. CPIS decrease of only 1 point is a failure. Clinical Pulmonary Infection Score of no change was considered a failure. Any CPIS increase from baseline was a failure). 2. All-cause mortality through EOT visit was a failure. 3. The development of empyema or lung abscess through the EOT visit was a failure.

    Measured: Up to 10 days after start of study treatment

  3. Number of Days on Mechanical Ventilation Through LFU Visit

    Number of days on mechanical ventilator was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived through the LFU visit, the ventilation days were actual days on ventilation with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days on ventilator was censored at 28 days. For participants who died or discontinued off ventilation, the number of days on ventilation was actual days on ventilation with a maximum value of 28 days. For participants who died or discontinued on ventilation, the number of days on ventilation was 28 days. Further analysis of the number of days on mechanical ventilator was to be performed with censoring at Day 28 for subset of participants on ventilation without censoring.

    Measured: Up to 28-32 days after start of study treatment

  4. Number of Days in the ICU Through LFU Visit

    Number of days in ICU was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived in ICU through the LFU visit, the ICU days were actual days in ICU with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days in ICU was censored at 28 days. For participants who died or discontinued in ICU, the number of days in ICU was 28 days. Further analysis of the number of days in ICU was to be performed with censoring at Day 28 for subset of participants on ventilation and without censoring.

    Measured: Up to 28-32 days after start of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2013 (estimated)
  2. Study start13 Apr 2013
  3. Primary completion7 Apr 2017
  4. Study completion7 Apr 2017

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
725 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01799993
Sponsor's protocol ID
13084
Other IDs
2013-001048-73
Acronym
INHALE 1
Status last verified
Jul 2018
First submitted
25 Feb 2013
Last updated
23 Jul 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Niederman MS, Alder J, Bassetti M, Boateng F, Cao B, Corkery K, Dhand R, Kaye KS, Lawatscheck R, McLeroth P, Nicolau DP, Wang C, Wood GC, Wunderink RG, Chastre J. Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial. Lancet Infect Dis. 2020 Mar;20(3):330-340. doi: 10.1016/S1473-3099(19)30574-2. Epub 2019 Dec 19.

    PubMed 31866328

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amikacin Inhalation Solution (BAY41-6551) in people with Pneumonia, Bacterial, run by Bayer at 65 sites in 12 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 7 inclusion and 10 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Canada, Mexico, Taiwan, Australia and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Surviving Through LFU Visit (time frame: Up to 28-32 days after start of study treatment). 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 NCT01799993, 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 23 Jul 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in