Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
NCT ID: NCT04160260
Last Updated: 2021-11-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2019-11-28
2020-04-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Omadacycline: Omadacycline Tablets
Omadacycline
Omadacycline: PO Tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Omadacycline
Omadacycline: PO Tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have a qualifying community-acquired bacterial pneumonia
* Has disease severity such that oral antibiotics therapy is appropriate
* Participants must not be pregnant at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
* Must be able to swallow tablets and comply with all of the requirements of the study
Exclusion Criteria
* Known or suspected infection caused by a pathogen that may be resistant to test article
* Participants who reside in a long-term care or nursing home
* Evidence of empyema
* Evidence of significant immunological disease
* Evidence of liver impairment or disease
* Evidence of unstable cardiac disease
* Severe renal disease or requirement for dialysis
* Evidence of septic shock
* Has a history of hypersensitivity or allergic reaction to any tetracycline
* Has received an investigational drug within the past 30 days
* Participants who are pregnant or nursing
* Unable or unwilling to comply with the protocol requirements
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Paratek Pharmaceuticals Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site 105
Birmingham, Alabama, United States
Site 102
San Diego, California, United States
Site 104
San Diego, California, United States
Site 111
Clearwater, Florida, United States
Site 116
Clearwater, Florida, United States
Site 106
Doral, Florida, United States
Site 108
Miami, Florida, United States
Site 110
Miami, Florida, United States
Site 112
West Palm Beach, Florida, United States
Site 103
Butte, Montana, United States
Site 114
Las Vegas, Nevada, United States
Site 101
Sherman, Texas, United States
Site 109
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PTK0796-CABPPO-19109
Identifier Type: -
Identifier Source: org_study_id