Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous 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 Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous 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


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 Fungal pneumonia Pneumocystis jiroveci pneumonia Aspiration pneumonia Other non-infectious causes of pulmonary infiltrates Primary or metastatic lung cancer Cystic fibrosis Active or suspected tuberculosis HIV or myasthenia 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 |
| --- | --- |
| Active Comparator: Moxifloxacin<br>Intravenous with the potential step-down to oral moxifloxacin | Drug: Moxifloxacin<br> <br> * Other names: Avelox;|
| Experimental: Solithromycin<br>Intravenous with potential step-down to oral solithromycin | Drug: Solithromycin<br> <br> * Other names: CEM-101;|

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 intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population | 72 [±12] hours after the first dose of study drug | 
| Clinical success rates in the ITT and Clinically Evaluable (CE) populations | To determine the overall clinical success rates of intravenous to 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