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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cempra Inc; Melinta Therapeutics, Inc.
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Solithromycin

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