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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT02531438
First received: July 14, 2015
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Bacterial Pneumonia
Community-Acquired Infections
Drug: Omadacycline
Drug: Moxifloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Paratek Pharmaceuticals Inc:

Primary Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 750
Study Start Date: November 2015
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02531438

  Show 140 Study Locations
Sponsors and Collaborators
Paratek Pharmaceuticals Inc
  More Information

Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02531438     History of Changes
Other Study ID Numbers: PTK0796-CABP-1200
Study First Received: July 14, 2015
Last Updated: January 24, 2017

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Community-Acquired Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Infection
Moxifloxacin
Fluoroquinolones
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

ClinicalTrials.gov processed this record on May 22, 2017