Trial · NCT01799993
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| OTHER_PRE_SPECIFIED | Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event | Up to 7 days after the end of study treatment | ITT for Safety population (included all participants in ITT analysis set who were analyzed as treated for safety analyses) | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Received at Least One Dose of Study Drug and Reported a Serious Adverse Event | Up to 7 days after the end of study treatment | ITT for Safety population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Organ Failure | Up to 7 days after the end of study treatment | ITT for Safety population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Death Due to Any Reason Through Day 10 and Day 15 | Up to 10 days and 15 days after start of study treatment, respectively | mITT population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01799993/outcomes