Trial · NCT01799993
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
NCT01799993, Phase 3, Completed, Bayer; results first posted 2018-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia. Trials, record NCT01799993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01799993
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
- NCT number
- NCT01799993
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 725 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Pneumonia, Bacterial
- Interventions
- Amikacin Inhalation Solution (BAY41-6551), Aerosolized Placebo
- First posted
- 2013-02-27
- Last updated
- 2018-07-23
- Other registries' IDs
- eudract:2013-001048-73
- Results first posted
- 2018-06-26
- Limitations and caveats
To shorten the time required to obtain data from the 2 clinical studies of Amikacin Inhale Phase 3 program, Bayer and the FDA decided that the results of studies NCT01799993 and NCT00805168 should be consolidated into a single report.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Surviving Through LFU Visit | Up to 28-32 days after start of study treatment | 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. |
| Secondary | Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit | Up to 28-32 days after start of study treatment | 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. |
| Secondary | Number of Participants With Early Clinical Response | Up to 10 days after start of study treatment | 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. |
| Secondary | Number of Days on Mechanical Ventilation Through LFU Visit | Up to 28-32 days after start of study treatment | 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. |
| Secondary | Number of Days in the ICU Through LFU Visit | Up to 28-32 days after start of study treatment | 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. |
| Other | Number of Participants With Microbiological Response Per Pathogen at TOC Visit | Up to 17-19 days after start of study treatment | The number of participants with microbiological response for each pathogen among the total number of participants with baseline pathogen isolates for each pathogen was determined. If a participant had 3 pathogens, all 3 were tabulated. Eradication ( defined as the absence of the original pathogen(s) at the post-treatment test-of-cure \[TOC\] visit culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) rates were reported to reveal the microbiological responses. The data were displayed for each bacterial genus/species. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory. |
| Other | Number of Participants With Microbiological Response at TOC Visit | Up to 17-19 days after start of study treatment | The responses of eradication (defined as the absence of the original pathogen(s) at the post-treatment TOC culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) were tabulated for each participant to reveal the microbiological responses. All pathogen isolates from a participant must be eradicated (or presumed eradicated) to tabulate an eradicated (or presumed eradicated) response. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory. |
| Other | Number of Participants With Microbiological Recurrence at LFU Visit | Up to 28-32 days after start of study treatment | The responses of recurrence were tabulated for each participant. Recurrence was defined as the reappearance of the original pathogen(s) from a specimen taken after the TOC visit. If one or more pathogen reappeared, all isolates from a participant were tabulated as "recurrence". Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory. |
| Other | Number of Participants With Emergence of New Respiratory Pathogens During the Aerosol Treatment Period | Up to 10 days after start of study treatment | New pathogens also denoted as superinfection was defined as the isolation of a new pathogen (not the original baseline pathogen) from a specimen taken while the participant was on antibiotic therapy (Day 1 to EOT) and having a need for alternative antimicrobial therapy. Rates of emergence of any new pathogen by participant after start of study drug were summarized for each treatment group. |
| Other | Number of Participants With Emergence of Resistance Among Pathogens | Up to 28-32 days after start of study treatment | Resistance to amikacin was determined for the bacterial isolates by using a standardized microbiology laboratory test that generates a minimum inhibitory concentration (MIC) for amikacin and bacterial isolate. The same microbiology resistance standard was used for all bacteria tested against amikacin. Resistant bacteria have a MIC value of 64 μg/mL or greater. Percentages of resistance were calculated based on the percentage of participants infected with any treatment-emergent pathogens resistant to amikacin. If a participant had a more than one occurrence of a specific pathogen during pre-treatment period, the worst case of testing was used. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Surviving Through LFU Visit | Up to 28-32 days after start of study treatment | Modified intent-to-treat (mITT) population (included all subjects who had a culture-confirmed Gram-negative bacteria that had been treated with at least one dose of study treatment, and had an APACHE II score ≥ 10 at the time of diagnosis of pneumonia) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit | Up to 28-32 days after start of study treatment | Participants who died through LFU visit in mITT population set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Early Clinical Response | Up to 10 days after start of study treatment | mITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Days on Mechanical Ventilation Through LFU Visit | Up to 28-32 days after start of study treatment | mITT population | day | MEAN |
| SECONDARY | Number of Days in the ICU Through LFU Visit | Up to 28-32 days after start of study treatment | mITT population without missing start or end dates | day | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Microbiological Response Per Pathogen at TOC Visit | Up to 17-19 days after start of study treatment | mITT population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Microbiological Response at TOC Visit | Up to 17-19 days after start of study treatment | mITT population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Microbiological Recurrence at LFU Visit | Up to 28-32 days after start of study treatment | mITT population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Emergence of New Respiratory Pathogens During the Aerosol Treatment Period | Up to 10 days after start of study treatment | mITT population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Emergence of Resistance Among Pathogens | Up to 28-32 days after start of study treatment | mITT population participants with pathogen susceptible to amikacin in pre-treatment period | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Surviving Through LFU Visit | Amikacin Inhale (BAY41-6551) | Clinical Success (Survive) | 191 | Participants | |
| Number of Participants Surviving Through LFU Visit | Placebo | Clinical Success (Survive) | 196 | Participants | |
| Number of Participants Surviving Through LFU Visit | Amikacin Inhale (BAY41-6551) | Clinical Failure (Did not survive) | 64 | Participants | |
| Number of Participants Surviving Through LFU Visit | Placebo | Clinical Failure (Did not survive) | 57 | Participants | |
| Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit | Amikacin Inhale (BAY41-6551) | Pneumonia-related mortality | 43 | Participants | |
| Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit | Placebo | Pneumonia-related mortality | 36 | Participants | |
| Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit | Amikacin Inhale (BAY41-6551) | Pneumonia-unrelated mortality | 21 | Participants | |
| Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit | Placebo | Pneumonia-unrelated mortality | 21 | Participants | |
| Number of Participants With Early Clinical Response | Amikacin Inhale (BAY41-6551) | Early Clinical Response - Success | 149 | Participants | |
| Number of Participants With Early Clinical Response | Placebo | Early Clinical Response - Success | 145 | Participants |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amikacin Inhale (BAY41-6551) | 362 | |
| Overall Study | STARTED | Placebo | 363 | |
| Overall Study | ITT Population | Amikacin Inhale (BAY41-6551) | 354 | |
| Overall Study | ITT Population | Placebo | 358 | |
| Overall Study | mITT Population | Amikacin Inhale (BAY41-6551) | 255 | |
| Overall Study | mITT Population | Placebo | 253 | |
| Overall Study | COMPLETED | Amikacin Inhale (BAY41-6551) | 229 | |
| Overall Study | COMPLETED | Placebo | 235 | |
| Overall Study | NOT COMPLETED | Amikacin Inhale (BAY41-6551) | 133 | |
| Overall Study | NOT COMPLETED | Placebo | 128 |
Source ClinicalTrials.gov
Adverse events276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Amikacin Inhale 400mg q12h | 36 | 353 | 38 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 44 | 359 | 49 |
| other | Coagulopathy | Blood and lymphatic system disorders | Amikacin Inhale 400mg q12h | 5 | 353 | 5 |
| other | Coagulopathy | Blood and lymphatic system disorders | Placebo | 10 | 359 | 11 |
| other | Atrial fibrillation | Cardiac disorders | Amikacin Inhale 400mg q12h | 9 | 353 | 9 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 10 | 359 | 10 |
| other | Tachycardia | Cardiac disorders | Amikacin Inhale 400mg q12h | 6 | 353 | 6 |
| other | Tachycardia | Cardiac disorders | Placebo | 11 | 359 | 11 |
| other | Constipation | Gastrointestinal disorders | Amikacin Inhale 400mg q12h | 30 | 353 | 30 |
| other | Constipation | Gastrointestinal disorders | Placebo | 32 | 359 | 32 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amikacin Inhale 400mg q12h | 86 | 353 |
| Total, all-cause mortality | Placebo | 85 | 359 |
| Total, other adverse events | Amikacin Inhale 400mg q12h | 207 | 353 |
| Total, other adverse events | Placebo | 214 | 359 |
| Total, serious adverse events | Amikacin Inhale 400mg q12h | 101 | 353 |
| Total, serious adverse events | Placebo | 97 | 359 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31866328 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event | Trial comparisons |
| Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants With Organ Failure | Trial comparisons |
| Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants With Emergence of Resistance Among Pathogens | Trial comparisons |
| Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants Who Received at Least One Dose of Study Drug and Reported a Serious Adverse Event | Trial comparisons |
| Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants With Microbiological Response at TOC Visit | Trial comparisons |
| Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants With Emergence of New Respiratory Pathogens During the Aerosol Treatment Period | Trial comparisons |
| Amikacin Inhale (BAY41-6551) vs Placebo: Number of Participants With Microbiological Recurrence at LFU Visit | Trial comparisons |
| Amikacin Inhale 400mg q12h vs Placebo: deaths from any cause | Trial comparisons |
| Amikacin Inhale 400mg q12h vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01799993
GET https://conductscience.org/api/trials/v1/NCT01799993/results?page=2