Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01168713
First received: July 22, 2010
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.


Condition Intervention Phase
Community-Acquired Bacterial Pneumonia
Drug: Levofloxacin
Drug: CEM-101
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral CEM-101 Compared to Oral Levofloxacin in the Treatment of Patients With Community-Acquired Bacterial Pneumonia

Resource links provided by NLM:


Further study details as provided by Cempra Pharmaceuticals:

Primary Outcome Measures:
  • Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit [ Time Frame: 5 to 10 days after the last dose of study drug ] [ Designated as safety issue: No ]
    Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment

  • Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit [ Time Frame: 5 to 10 days after the last dose of study drug ] [ Designated as safety issue: No ]
    Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment


Secondary Outcome Measures:
  • By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ] [ Designated as safety issue: No ]
    Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen.

  • By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit [ Time Frame: 5 to 10 days after the last dose of study drug ] [ Designated as safety issue: No ]
    Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

  • By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ] [ Designated as safety issue: No ]
    Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

  • By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit [ Time Frame: 5 to 10 days after the last dose of study drug ] [ Designated as safety issue: No ]
    Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

  • Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT) [ Time Frame: 5 days of study drug treatment ] [ Designated as safety issue: No ]
    Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

  • Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ] [ Designated as safety issue: No ]
    Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

  • Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ] [ Designated as safety issue: No ]
    Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

  • Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ] [ Designated as safety issue: No ]
    Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

  • Early Clinical Response in the intent to treat (ITT) population at Day 3 [ Time Frame: 3 days of study drug treatment ] [ Designated as safety issue: No ]
    Clinical success is defined as being both clinically stable and showing clinical improvement based on the symptoms of community acquired bacterial pneumonia (CABP)

  • Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population [ Time Frame: Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit) ] [ Designated as safety issue: No ]
    Resolution of all baseline signs and symptoms in the clinically evaluable (CE) population

  • Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production [ Time Frame: 3 days of study drug treatment ] [ Designated as safety issue: No ]
    Resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

  • Percentage of patients at the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production [ Time Frame: 5 days of study drug treatment ] [ Designated as safety issue: No ]
    resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

  • Percentage of patients at Day 3 who are clinically stable [ Time Frame: 3 days of study drug treatment ] [ Designated as safety issue: No ]

    clinical stability defined as:

    • Temperature <=37.8°C
    • Heart rate <=100 beats/min
    • Systolic blood pressure ≥90 mm Hg
    • Ability to maintain oral intake
    • Normal mental status (oriented to person, place or time)

  • Percentage of patients at the end of treatment (EOT) who are clinically stable [ Time Frame: 5 days of study drug treatment ] [ Designated as safety issue: No ]

    Clinically stable defined as:

    • Temperature ≤37.8°C
    • Heart rate ≤100 beats/min
    • Systolic blood pressure ≥90 mm Hg
    • Ability to maintain oral intake
    • Normal mental status (oriented to person, place or time)


Enrollment: 132
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levofloxacin Drug: Levofloxacin

Levofloxacin once daily for 5 days:

Levofloxacin 750 mg PO Days 1-5

Other Name: Levaquin
Experimental: CEM-101 Drug: CEM-101

CEM-101 once daily for 5 days:

CEM-101 800 mg PO Day 1

CEM-101 400 mg PO Days 2-5

Other Name: Solithromycin

Detailed Description:

Community-acquired bacterial pneumonia is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity again CABP pathogens. CEM-101 is the first fluoroketolide with excellent in vitro and in vivo activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of community acquired bacterial pneumonia (e.g. cough with purulent sputum or change in character of sputum consistent with bacterial infection, dyspnea or tachypnea, chest pain due to pneumonia, fever, presence of rales and/or signs of consolidation).
  2. No prior systemic antibacterial therapy, unless failed other therapy.
  3. Chest Xray shows new lobar or multilobar infiltrate(s) consistent with acute bacterial pneumonia.
  4. PORT Risk Class II, III, or IV <=105
  5. Ability to take oral medication.

Exclusion Criteria:

  1. Severe chronic obstructive pulmonary disease FEV1 <30%.
  2. Hospitalization within 90 days or residence in a long-term-care facility within 30 days prior to the onset of symptoms
  3. Chemotherapy or radiation therapy within the previous 3 months.
  4. Significant hepatic, hematological, renal abnormalities.
  5. Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g. life expectancy <30 days).
  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: NCT01168713

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Sponsors and Collaborators
Cempra Pharmaceuticals
  More Information

No publications provided by Cempra Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cempra Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01168713     History of Changes
Other Study ID Numbers: CE01-200
Study First Received: July 22, 2010
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Cempra Pharmaceuticals:
Adults with Community-Acquired Bacterial Pneumonia

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014