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

Phase 3

Completed

Interventions: Drug: Solithromycin
Drug: Moxifloxacin
Other: Placebo to match solithromycin

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Solithromycin	Placebo to match 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
Solithromycin	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
Moxifloxacin	Moxifloxacin	Moxifloxacin 400 mg PO daily on Day 1 through Day 7

Primary Outcome Measures

Name	Time	Method
Early clinical response rate in the Intent to Treat (ITT) population	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

Name	Time	Method
Clinical success rates in the ITT and Clincally Evaluable (CE) populations	5 to 10 days after the last dose of study drug	To determine the overall clinical success rates of oral solithromycin compared to moxifloxacin
Early clinical response rate in the microITT population	72 [±12] hours after the first dose of study drug	To determine NI in early clinical response rate of oral solithromycin compared to oral moxifloxacin in the mITT population