Phase II Study of Oral Nafithromycin in CABP
Status: | Completed |
---|---|
Conditions: | Pneumonia |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/2/2018 |
Start Date: | September 2016 |
End Date: | July 2017 |
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
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
Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial
Pneumonia (CABP) in Adults
Inclusion Criteria:
Meet the clinical criteria for CABP based on following:
1. Clinical symptoms (new or worsening)
2. Vital sign abnormalities
3. Laboratory abnormalities
4. Radiographic evidence of CABP
5. PORT score
Exclusion Criteria:
1. Subjects with any of the following confirmed or suspected types of pneumonia:
1. Aspiration pneumonia
2. Hospital-acquired bacterial pneumonia (HABP)
3. Healthcare-associated bacterial pneumonia (HCAP)
4. Ventilator-associated bacterial pneumonia (VABP)
5. Pneumonia that may be caused by pathogen(s) resistant to either study drug
2. Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial
treatment for treatment of the current CABP
3. Suspected or confirmed non-infectious causes of pulmonary infiltrates
4. Subjects requiring concomitant adjunctive or additional potentially-effective systemic
antibacterial treatment for management of CABP
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6
sites
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1155 Purchase Street
Bedford, Massachusetts 02740
Bedford, Massachusetts 02740
Phone: +1 (508) 997 2900
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