Phase II Study of Oral Nafithromycin in CABP

Study Overview
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Brief Summary
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Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

Official Title
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A Phase II, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

Conditions
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Community-Acquired Bacterial Pneumonia (CABP)

Intervention / Treatment
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* Drug: Nafithromycin 800 mg 3 days
* Drug: Nafithromycin 800 mg 5 days
* Drug: Moxifloxacin 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the clinical criteria for CABP based on following: Clinical symptoms (new or worsening) Vital sign abnormalities Laboratory abnormalities Radiographic evidence of CABP PORT score Exclusion Criteria: Subjects with any of the following confirmed or suspected types of pneumonia: Aspiration pneumonia Hospital-acquired bacterial pneumonia (HABP) Healthcare-associated bacterial pneumonia (HCAP) Ventilator-associated bacterial pneumonia (VABP) Pneumonia that may be caused by pathogen(s) resistant to either study drug Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP Suspected or confirmed non-infectious causes of pulmonary infiltrates Subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of CABP

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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nafithromycin 800 mg 3 days<br>PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind | Drug: Nafithromycin 800 mg 3 days<br> <br> |
| Experimental: Nafithromycin 800 mg 5 days<br>PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind | Drug: Nafithromycin 800 mg 5 days<br> <br> |
| Active Comparator: Moxifloxacin 400 mg<br>PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind | Drug: Moxifloxacin 400 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response in the ITT Population | The primary efficacy endpoint was clinical response (response, non-response, or indeterminate) at Day 4, tested in the ITT population. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance | Day 4 from start of drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response in the Micro-ITT Population | Clinical response (response, non-response, or indeterminate) at Day 4 was also tested in the micro-ITT population as a secondary efficacy endpoint. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance | Day 4 from start of drug administration |