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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.
 
ClinicalTrials.gov Identifier: NCT02531438
Recruitment Status : Completed
First Posted : August 24, 2015
Results First Posted : November 29, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

Study Description
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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 Design
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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

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Early Clinical Response [ Time Frame: Screening; 72 to 120 hours after the first dose of test article ]
    Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response was determined programmatically using the investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in CABP symptoms, worsening of any CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event, or death.


Secondary Outcome Measures :
  1. Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit [ Time Frame: Screening; 5 to 10 days after the last day of therapy ]
    At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.

  2. Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CT-PTE) Population [ Time Frame: Screening; 5 to 10 days after the last day of therapy ]
    At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02531438


Locations
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Sponsors and Collaborators
Paratek Pharmaceuticals Inc
  Study Documents (Full-Text)

Documents provided by Paratek Pharmaceuticals Inc:
Study Protocol and Statistical Analysis Plan  [PDF] March 17, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02531438    
Other Study ID Numbers: PTK0796-CABP-1200
First Posted: August 24, 2015    Key Record Dates
Results First Posted: November 29, 2018
Last Update Posted: January 16, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Bacterial
Community-Acquired Infections
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Bacterial Infections
Bacterial Infections and Mycoses
 Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents