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Trial record 12 of 141 for:    "Pneumonia, Bacterial"

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

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ClinicalTrials.gov Identifier: NCT01968733
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Cempra 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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 863 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 Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
Study Start Date : November 2013
Primary Completion Date : July 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Moxifloxacin
Intravenous with the potential step-down to oral moxifloxacin
Drug: Moxifloxacin
Other Name: Avelox
Experimental: Solithromycin
Intravenous with potential step-down to oral solithromycin
Drug: Solithromycin
Other Name: CEM-101



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 intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population

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



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

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
  • Fungal pneumonia
  • Pneumocystis jiroveci pneumonia
  • Aspiration pneumonia
  • Other non-infectious causes of pulmonary infiltrates
  • Primary or metastatic lung cancer
  • Cystic fibrosis
  • Active or suspected tuberculosis
  • HIV or myasthenia 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 ClinicalTrials.gov identifier (NCT number): NCT01968733


  Show 269 Study Locations
Sponsors and Collaborators
Cempra Inc
Investigators
Study Director: Brian D Jamieson, MD Cempra Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cempra Inc
ClinicalTrials.gov Identifier: NCT01968733     History of Changes
Other Study ID Numbers: CE01-301
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Cempra Inc:
Pneumonia
CABP
CAP
Macrolide

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
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