Trial record 10 of 90 for:    "Pneumonia, Bacterial"

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

This study is currently recruiting participants.
Verified April 2014 by Cempra Pharmaceuticals
Information provided by (Responsible Party):
Cempra Pharmaceuticals Identifier:
First received: December 20, 2012
Last updated: April 10, 2014
Last verified: April 2014

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 Oral Solithromycin (CEM-101) Compared 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 Pharmaceuticals:

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 oral solithromycin compared to oral moxifloxacin in the mITT population

  • Clinical success rates in the ITT and Clincally 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 oral solithromycin compared to moxifloxacin

Estimated Enrollment: 860
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Moxifloxacin
Moxifloxacin 400 mg PO daily on Day 1 through Day 7
Drug: Moxifloxacin
Other Name: Avelox

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
  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT01756339

Contact: Kay Clark, RN

  Show 142 Study Locations
Sponsors and Collaborators
Cempra Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cempra Pharmaceuticals Identifier: NCT01756339     History of Changes
Other Study ID Numbers: CE01-300
Study First Received: December 20, 2012
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cempra Pharmaceuticals:

Additional relevant MeSH terms:
Pneumonia, Bacterial
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 21, 2014