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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02531438
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : February 14, 2018
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Community-Acquired Infections Drug: Omadacycline Drug: Moxifloxacin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2015
Actual Primary Completion Date : February 5, 2017
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Omadacycline
Omadacycline IV; Omadacycline tablets
Drug: Omadacycline
Injection for IV; Oral tablets

Active Comparator: Moxifloxacin
Moxifloxacin IV; Moxifloxacin tablets
Drug: Moxifloxacin
IV solution; Oral tablets
Other Name: Avelox

Primary Outcome Measures :
  1. 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) [ Time Frame: 72-120 hours after first dose of study drug ]
    Symptoms include cough, sputum production, pleuritic chest pain and dyspnea

  2. Number of subjects with clinical success at the post treatment evaluation visit defined as survival after test article completion and symptom resolution [ Time Frame: 5-10 days after the last day of therapy ]
    Symptoms include cough, sputum production, pleuritic chest pain and dyspnea

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02531438

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Sponsors and Collaborators
Paratek Pharmaceuticals Inc

Responsible Party: Paratek Pharmaceuticals Inc Identifier: NCT02531438     History of Changes
Other Study ID Numbers: PTK0796-CABP-1200
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Pneumonia, Bacterial
Community-Acquired Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors