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

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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

Tracking Information
First Submitted Date  ICMJE July 14, 2015
First Posted Date  ICMJE August 24, 2015
Results First Submitted Date  ICMJE November 2, 2018
Results First Posted Date  ICMJE November 29, 2018
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date February 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • 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 hours after first dose of study drug ]
    Symptoms include cough, sputum production, pleuritic chest pain and dyspnea
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bacterial Pneumonia
  • Community-Acquired Infections
Intervention  ICMJE
  • Drug: Omadacycline
    Injection for IV; Oral tablets
  • Drug: Moxifloxacin
    IV solution; Oral tablets
    Other Name: Avelox
Study Arms  ICMJE
  • Experimental: Omadacycline
    Omadacycline IV; Omadacycline tablets
    Intervention: Drug: Omadacycline
  • Active Comparator: Moxifloxacin
    Moxifloxacin IV; Moxifloxacin tablets
    Intervention: Drug: Moxifloxacin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2017)
774
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2015)
750
Actual Study Completion Date  ICMJE March 10, 2017
Actual Primary Completion Date February 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Bulgaria,   Croatia,   Czechia,   Georgia,   Germany,   Greece,   Hungary,   Israel,   Korea, Republic of,   Latvia,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02531438
Other Study ID Numbers  ICMJE PTK0796-CABP-1200
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paratek Pharmaceuticals Inc
Study Sponsor  ICMJE Paratek Pharmaceuticals Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Paratek Pharmaceuticals Inc
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP