Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia

Completed · Phase 1

Conditions studied: Community-acquired Pneumonia

In brief

The purpose of this study is to evaluate the pharmacokinetics of an oral omadacycline dosing regimen in the treatment of adults with CABP.

Key facts

Study ID

NCT04160260

Run by

Paratek Pharmaceuticals Inc

People needed

18

Starts

2019-11-28

Expected to finish

2020-04-13

Last updated by the study team

2021-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants, age 18 or older who have signed the informed consent form
• 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

You may not qualify if…

• Has received more than 24 hours of a potentially effective systemic antibacterial therapy within the 72 hours prior to the first dose of test article
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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