None listed
Conditions
Interventions
GROUP A Type of group
This group will be treated with EDP-420 400 mg (In capsules of 100 mg) QD PO + 2 capsules of Telithromycin Placebo QD PO on Day 1. EDP-420 200 mg (In capsules of 100 mg) QD PO + 2 capsules of Telithromycin Placebo on Days 2 and 3. 2 capsules of Telithromycin Placebo QD PO on days 4-7.
Group name:GROUP B Type of group
This group will be treated with EDP-420 800 mg (In capsules of 400 mg) QD PO + Telithromycin 2400 mg (in encapsulated tablets) QD PO on Days 1, 2 and 3. Telithromycin 2400 mg (in encapsulated tablets) QD PO in on days 4 - 7.
Sponsors
ENANTA PHARMACEUTICALS INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation that will determine: 1) Clinical cure (Complete resolution or improvement of all signs and symptoms of pneumonia and improvement or lack of progression of all abnormalities on chest radiographs). 2) Clinical failure (persistence or worsening of signs or symptoms after 3 days of therapy or need for an additional antibiotic or failure to show improvement in at least three of the clinical findings after 3 days of therapy or initial improvement of at least three of the signs and symptoms followed by a clinically significant worsening or Development of a new lung infection from an extrapulmonary infection, requiring different or additional antimicrobial therapy to the study medication or Progression of abnormalities on chest x-ray or Death due to pneumonia). 3) Undetermined (The evaluation was not possible). Measure:Clinical result. Timepoints:Monitoring of clinical response: Days 15 and 17 of the study. Chest x-ray: Days 1 or 2, on days 3 to 10 if clinically indicated, on days 16 - 17. ; Outcome name:Adverse events: Clinical evaluation in which they will be coded by system class and preferred organ and term using MedDRA. Clinical laboratory tests: Hematology and serum chemistry panels. Other safety variables: 12-lead ECG, physical examination, vital signs. Measure:Safety of treatment: Adverse events. Clinical laboratory tests. Other security variables. Timepoints:Adverse events: Day 1, evaluation 2 (days 3-5), evaluation 3 (days 8-19), evaluation 5 (days 15-17) and evaluation 5 (days 18-32). Clinical laboratory tests, physical examination: Day 1 and evaluation 5 (days 15-17. 12-lead ECG, vital signs: Day 1, evaluation 2 (days 3-5), evaluation 3 (days 8-19) and evaluation 5 (days 15-17). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Culture and evaluation of antibiotic susceptibility. Its results will be cataloged as: Alleged eradication, eradication, presumed persistence, persistence, indeterminate, recurrence, superinfection, new infection, colonization. Chest X-ray: The researcher will compare the findings of the chest x-rays obtained in the Evaluation 4 with the findings of the Evaluation 1. The results will be classified as: Resolution, improvement, without change, worsening, indeterminate. Measure:Bacteriological response. Bacteriological cure rate. Rate of eradication of the pathogen. Radiological response. Change from Evaluation 1 in signs and symptoms. Timepoints:Cultivation and evaluation of antibiotic susceptibility: Day 1 and evaluation 4 (Days 15 - 17). Chest x-ray: Days 1 or 2, on days 3 to 10 if clinically indicated, on days 16 - 17. ; Outcome name:Legionella pneumophila: Serology (IgG or IgM) + positive urinary antigen for Serogroup I L. pneumophila. Chlamydophila pneumoniae: IgG / Ig M Ig by microinmunofluorescence of paired sera titrations. Mycoplasma pneumoniae: IgM titration - 1:16. Measure:Diagnosis of infections caused by atypical pathogens. Timepoints:Day 1 of the study and visit 4 (days 15-17). | — |
Countries
Peru, United States
Outcome results
None listed