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Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

Information source: Paratek Pharmaceuticals Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Pneumonia; Community-Acquired Infections

Intervention: Omadacycline (Drug); Moxifloxacin (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Paratek Pharmaceuticals Inc

Overall contact:
Courtney Kirsch, Email: ckirsch@paratekpharm.com


The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.

Clinical Details

Official title: A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Number of subjects with clinical success at the early clinical response assessment visit as defined by survival with improvement on 2 of 4 symptoms of community acquired bacterial pneumonia (CABP)

Number of subjects with clinical success at the post treatment evaluation visit defined as survival after test article completion and symptom resolution


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients, ages 18 years or older who have signed the informed consent

- Has qualifying bacterial pneumonia

- Female patients 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 Exclusion Criteria:

- Known or suspected hospital-acquired pneumonia

- Evidence of significant immunological disease

- Has a history of hypersensitivity or allergic reaction to any tetracycline or to any

fluoroquinolone antibiotic

- Has received an investigational drug within past 30 days

- Women who are pregnant or nursing

Locations and Contacts

Courtney Kirsch, Email: ckirsch@paratekpharm.com

Additional Information

Starting date: November 2015
Last updated: August 20, 2015

Page last updated: August 23, 2015

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