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. (see Contacts and Locations)
Verified May 2014 by Cempra Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01756339
First received: December 20, 2012
Last updated: June 24, 2014
Last verified: May 2014
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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
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: NCT01756339

Contacts
Contact: Kay Clark, RN kclark@cempra.com

  Show 116 Study Locations
Sponsors and Collaborators
Cempra Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cempra Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01756339     History of Changes
Other Study ID Numbers: CE01-300
Study First Received: December 20, 2012
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cempra Pharmaceuticals:
Pneumonia
CABP
CAP
Macrolide

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

ClinicalTrials.gov processed this record on July 24, 2014