Community Acquired Pneumonia
Conditions
Brief summary
This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia
Interventions
DRUGEDP-420 / Duration of Treatment - 3 days
DRUGTelithromycin / Duration of Treatment - 7 days
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia. * Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact * If female, must be non-lactating and at no risk for pregnancy
Exclusion criteria
* Other infections * Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy * History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins * Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality * Requirement of parenteral antimicrobial therapy for treatment of pneumonia * Currently receiving or likely to receive any known inhibitors or inducers of cytochrome P450 mediated drug metabolism * Immunocompromised subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Cure 7-14 days after end of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacteriological response | — |
| Radiographic response | — |
| Change in signs and symptoms | — |
| Safety | — |
Countries
United States
Contacts
Primary ContactMedical Director
Outcome results
None listed