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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Community-acquired Bacterial Pneumonia

Intervention / Treatment
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* Drug: Solithromycin
* Drug: Moxifloxacin
* Other: Placebo to match solithromycin


Participation Criteria
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Eligibility Criteria
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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): Cough Production of purulent sputum Shortness of breath (dyspnea) Chest pain due to pneumonia At least 1 of the following: Fever Hypothermia 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: Viral or fungal pneumonia Pneumocystis jiroveci pneumonia Aspiration pneumonia Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure) Primary or metastatic lung cancer Cystic fibrosis Active or suspected tuberculosis Known HIV or myasthesia gravis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solithromycin<br>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<br> <br> * Other names: CEM-101;Other: Placebo to match solithromycin<br> <br> |
| Active Comparator: Moxifloxacin<br>Moxifloxacin 400 mg PO daily on Day 1 through Day 7 | Drug: Moxifloxacin<br> <br> * Other names: Avelox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early clinical response rate in the Intent to Treat (ITT) population | 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. | 72 [±12] hours after the first dose of study drug | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, CABP, CAP, Macrolide