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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2011

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.

Interventions

  • Drug: Levofloxacin
    • Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5
  • 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

Arms, Groups and Cohorts

  • Active Comparator: Levofloxacin
  • Experimental: CEM-101

Clinical Trial Outcome Measures

Primary 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
    • 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
    • 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 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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)
    • 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
    • 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
    • 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
    • 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
    • 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)

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Melinta Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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