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Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia (SOLITAIRE-ORAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756339
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

Brief Summary:
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Condition or disease Intervention/treatment Phase
Community-acquired Bacterial Pneumonia Drug: Solithromycin Drug: Moxifloxacin Other: Placebo to match solithromycin Phase 3

Detailed Description:
Community-acquired bacterial pneumonia (CABP) 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 against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
Study Start Date : December 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Solithromycin
Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7
Drug: Solithromycin
Other Name: CEM-101

Other: Placebo to match solithromycin
Active Comparator: Moxifloxacin
Moxifloxacin 400 mg PO daily on Day 1 through Day 7
Drug: Moxifloxacin
Other Name: Avelox

Primary Outcome Measures :
  1. Early clinical response rate in the Intent to Treat (ITT) population [ Time Frame: 72 [±12] hours after the first dose of study drug ]
    To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.

Secondary Outcome Measures :
  1. Early clinical response rate in the microITT population [ Time Frame: 72 [±12] hours after the first dose of study drug ]
    To determine NI in early clinical response rate of oral solithromycin compared to oral moxifloxacin in the mITT population

  2. Clinical success rates in the ITT and Clincally Evaluable (CE) populations [ Time Frame: 5 to 10 days after the last dose of study drug ]
    To determine the overall clinical success rates of oral solithromycin compared to moxifloxacin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female patients ≥ 18 years of age
  • An acute onset of at least 3 of the following signs and symptoms (new or worsening):

    1. Cough
    2. Production of purulent sputum
    3. Shortness of breath (dyspnea)
    4. Chest pain due to pneumonia
  • At least 1 of the following:

    1. Fever
    2. Hypothermia
    3. Presence of pulmonary rales and/or evidence of pulmonary consolidation
  • PORT Risk Class II, III, or IV
  • Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study
  • Not received any systemic antibiotics during the prior 7 days

Exclusion Criteria:

  • Ventilator-associated pneumonia
  • Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease
  • Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms
  • Presence of known:

    1. Viral or fungal pneumonia
    2. Pneumocystis jiroveci pneumonia
    3. Aspiration pneumonia
    4. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)
    5. Primary or metastatic lung cancer
    6. Cystic fibrosis
    7. Active or suspected tuberculosis
  • Known HIV or myasthesia gravis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756339

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Sponsors and Collaborators
Melinta Therapeutics, Inc.
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Study Director: David Oldach, MD Melinta Therapeutics, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Melinta Therapeutics, Inc. Identifier: NCT01756339    
Other Study ID Numbers: CE01-300
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Keywords provided by Melinta Therapeutics, Inc.:
Additional relevant MeSH terms:
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Pneumonia, Bacterial
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents