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Completed

NCT Number: NCT01168713

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

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.

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Key information

Conditions

Community-acquired Bacterial Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • No prior systemic antibacterial therapy, unless failed other therapy.
  • Chest Xray shows new lobar or multilobar infiltrate(s) consistent with acute bacterial pneumonia.
  • PORT Risk Class II, III, or IV <=105
  • Ability to take oral medication.

Exclusion criteria

  • Severe chronic obstructive pulmonary disease FEV1 <30%.
  • Hospitalization within 90 days or residence in a long-term-care facility within 30 days prior to the onset of symptoms
  • Chemotherapy or radiation therapy within the previous 3 months.
  • Significant hepatic, hematological, renal abnormalities.
  • 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).

Treatment and study plan

Levofloxacin

Drug

Levofloxacin once daily for 5 days:

Levofloxacin 750 mg PO Days 1-5

Other names: Levaquin

CEM-101

Drug

CEM-101 once daily for 5 days:

CEM-101 800 mg PO Day 1

CEM-101 400 mg PO Days 2-5

Other names: Solithromycin

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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)

  10. 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

  11. 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

  12. 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

  13. 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)

  14. 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)

Sponsors and collaborators

Lead sponsor

Melinta Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2010
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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