Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia
- Conditions
- -J189 Pneumonia, unspecifiedPneumonia, unspecifiedJ189
- Registration Number
- PER-025-06
- Lead Sponsor
- ENANTA PHARMACEUTICALS INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female between 18 and 65 years of age.
2. Women should not be breastfeeding and should plan their birth with an acceptable method.
3. Subjects should have a chest radiograph consistent with pneumonia according to the interpretation of a radiologist.
4. The subjects should undergo a 12-lead electrocardiogram at rest in the screening that shows no clinically significant abnormality and a QTc (Bazett correction) <450 msec for men and <470 msec for women.
5. Subjects should be able to take antibiotic treatment orally and should be able to swallow intact large capsules.
6. The subject must have a recent respiratory illness, which is consistent with the diagnosis of community-acquired pneumonia.
7. Purulent sputum graded by Gram stain should be obtained within 48 hours pretreatment for a routine bacterial culture with sensitivity test.
8. A written consent report signed voluntarily by the subject (or his legal representative) must be obtained prior to the initiation of any procedure related to the study.
1. Hospitalization in the previous 4 weeks or stay in a chronic care facility.
2. Evidence of active tuberculosis (or other mycobacterial infection), empyema, lung abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor involving the lung, bronchial obstruction, history of post-obstructive pneumonia, or suspicion or confirmation of Pneumocystis pneumonia jiroveci
3. Treatment with long-term injectable antimicrobial agents in the last 4 weeks or other systemic antibiotics in the last 2 weeks.
4. Any infection that requires the use of an antimicrobial in concomitant form in addition to the study drug.
5. History of hypersensitivity, allergy or adverse reactions to macrolides, ketolides, azalides or streptogramin.
6. Treatment with a research drug in the last 4 weeks before the administration of the study drug.
7. Pregnant or breastfeeding women.
8. Renal or hepatic insufficiency known (or disease).
9. Evidence of cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease not controlled, malignancy or other abnormality.
10. Subjects requiring parenteral antimicrobial therapy for the treatment of community-acquired pneumonia should not be included in this study.
11. Any underlying condition or disease that may interfere with the performance of the study procedures and evaluations or absorption of the drug.
12. Who is currently receiving or receiving short-term any known inhibitor or inducer of drug metabolism mediated by cytochrome P450.
13. Immunocompromised subjects.
14. Previous treatment in this study or another study with EDP-420.
15. Subjects> 50 years with any of the following: a) Respiratory frequency> 30 / minute. b) Systolic blood pressure <90 mm Hg. c) Temperature <35 ° C or ~ 40 ° C. d) Pulse> 125 per minute.
16. Subjects currently receiving or ready to receive Class 1 A or Class III antiarrhythmic agents from evaluation 1 to 48 hours after the last dose of study medication.
17. Subjects with myasthenia gravis.
18. Subjects with bronchiectasis and history of a recent respiratory infection caused by Pseudomonas aeruginosa or other Gram-negative bacilli.
19. Family or personal history of QTc prolongation or proarrhythmic conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method