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)

This study has been completed.
Information provided by (Responsible Party):
Cempra Inc
ClinicalTrials.gov Identifier:
First received: October 21, 2013
Last updated: November 3, 2015
Last verified: November 2015
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Condition Intervention Phase
Community-acquired Bacterial Pneumonia
Drug: Solithromycin
Drug: Moxifloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Cempra Inc:

Primary Outcome Measures:
  • Early clinical response rate in the Intent to Treat (ITT) population. [ Time Frame: 72 [±12] hours after the first dose of study drug ] [ Designated as safety issue: No ]
    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:
  • Early clinical response rate in the microITT population [ Time Frame: 72 [±12] hours after the first dose of study drug ] [ Designated as safety issue: No ]
    To determine NI in early clinical response rate of intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population

  • Clinical success rates in the ITT and Clinically Evaluable (CE) populations [ Time Frame: 5 to 10 days after the last dose of study drug ] [ Designated as safety issue: No ]
    To determine the overall clinical success rates of intravenous to oral solithromycin compared to moxifloxacin

Enrollment: 863
Study Start Date: November 2013
Study Completion Date: September 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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
  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: NCT01968733

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

Responsible Party: Cempra Inc
ClinicalTrials.gov Identifier: NCT01968733     History of Changes
Other Study ID Numbers: CE01-301 
Study First Received: October 21, 2013
Last Updated: November 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cempra Inc:

Additional relevant MeSH terms:
Pneumonia, Bacterial
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reproductive Control Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 23, 2016