None listed
Conditions
Interventions
GROUP A Type of group
This group will be treated with Cetromycin 150 mg, 2 tablets (in capsules) for a daily dose of 300 mg, QD, PO. + 2 capsules of Placebo QD, PO. This scheme will be followed for a total of 7 days.
Group name:GROUP B Type of group
This group will be treated with Clarithromycin 250 mg, in capsule, BID, PO. + 2 Placebo BID capsules, PO. This scheme will be followed for a total of 7 days.
Sponsors
ADVANCE LIFE SCIENCE, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory subjects men or women over 18 years of age. 2. Women should not be breastfeeding or have any risk of pregnancy for one of the following reasons: a) Postmenopausal for at least 1 year, surgically sterile or b) if they are of childbearing age, the subject should have a Pregnancy analysis of human chorionic gonadotropin (HCG) negative and should be using a highly effective method of birth control during the course of the study. 3. The subject should have a chest radiograph that indicated a clinical diagnosis of bacterial pneumonia according to the interpretation of the radiologist. 4. The subject should be a suitable candidate for oral antibiotic therapy and should be able to swallow the capsules intact. 5. The subject must present a recent respiratory disease that, based on the consideration of the signs and symptoms after the physical examination, is consistent with the diagnosis of bacterial CAP. 6. It is necessary that samples of the subjects are collected for microbiological documentation within 48 hours prior to enrollment. 7. Voluntary informed consent must be obtained in writing by the subject (or his / her legal representative) before the beginning of any procedure related to the study.
Exclusion criteria
Exclusion criteria: 1. A previous hospitalization within the previous 4 weeks or residency in a chronic care unit. 2. Evidence of active tuberculosis, empyema, lung abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor that compromises the lung, bronchial obstruction, history of postobstructive pneumonia or pneumonia Pneumocystis carinii known or suspected of the same. 3. Treatment with a long-acting injectable antimicrobial agent within 4 weeks, treatment with antibiotics such as ceftriaxone, azithromycin or dirithromycin within 7 days, or subjects who have received more than 24 hours of treatment with other antibiotics within 7 days prior to the administration of the study medication. 4 weeks, treatment with antibiotics such as ceftriaxone, azithromycin or dirithromycin within 7 days, or subjects who have received more than 24 hours of treatment with other antibiotics within 7 days. days prior to the administration of the study medication. 4. Any infection that requires the use of a concomitant antimicrobial agent in addition to the study medication. 5. History of hypersensitivity or allergic reactions to antimicrobial agents macrolides, ketolides, quinolones, azolides or streptogramins. 6. Treatment with a research medication within 4 weeks prior to the administration of the study medication. 7. Subjects women who are pregnant or breastfeeding. 8. Subjects with significant known liver or kidney deterioration (or disease). 9. Subjects with a history of renal dysfunction. 10. Evidence of cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy or other abnormality of uncontrolled clinical importance. 11. Subjects who would need parenteral antimicrobial therapy for the treatment of pneumonia should not enroll in the study. 12. Any underlying morbid condition or picture that could interfere with the implementation of study procedures and evaluations or the absorption of study medication. 13. Currently, they receive or are likely to receive any of the following medications: Astemizole (Hismanal®) or Pimozide (Orap®). 14. At present, they are receiving or are likely to receive any of the following medications: a) Theophylline or any theophylline analog. b) carbamazepine, dexamethasone, phenobarbital, phenytoin, hypericum, lamotrigine, troglitazone, warfarin and digitalis glycoside. c) Midazolam, triazolam and alprazolam. d) Simvastatin, lovastatin and atorvastatin. 15. Subject who is currently receiving or likely to need any of the following medications: a) Other systemic antibiotic therapy. b) Rifampin or rifabutin. 16. Immunocompromised subjects. 17. Subjects with knowledge or suspicion of a CNS disorder that may predispose the subject to suffer seizures or lower the seizure threshold. 18. Previous treatment in this study or another study of cetromycin. 19. Subjects with signs of septic shock.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation in which clinical cure is evaluated, defined as the improvement or return to the state prior to infection or lack of progression in all pulmonary infiltrates originally consistent with pneumonia on chest radiography. And, resolution of all signs and symptoms of CAP originally present at the time of enrollment. Measure:Clinical cure rate in the visit of the Healing Test. Timepoints:Days 14-22. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Bacteriological response rate: Will be evaluated based on culture results. Classifying the results in: Presumed eradication, Eradication, Colonization, Presumed resistance, Persistence, Superinfection, Recurrence, New infection, Indeterminate. 2) Radiographic response rate: Clinical evaluation of the radiographic signs of pneumonia. 3) Change in the signs and symptoms regarding the baseline visit: Clinical evaluation. Measure:Secondary efficacy: 1) Bacteriological response rate. 2) Radiographic response rate. 3) Change in the signs and symptoms regarding the baseline visit. Timepoints:Healing test: Days 14-22. ; Outcome name:1) Incidence of adverse events: Clinical evaluation, where an adverse event in any unfavorable medical event in a patient or subject of a clinical investigation that has been administered a pharmaceutical product that does not necessarily have a causal relationship with such treatment. 2) Changes in laboratory parameters: Panels of serum chemistry and hematology 3) Changes in vital signs: Blood pressure (after 3 minutes in sitting position), pulse in 30 seconds, respiratory rate and oral temperature. 4) Changes in ECG results: Evaluation of heart rate; PR, QRS, QT and QTc Measure:Security: 1) Incidence of adverse events. 2) Changes in laboratory parameters. 3) Changes in vital signs. 4) Changes in ECG results. Timepoints:Days 4-6, 24-72 hours after therapy, Days 14-22. , through telephone contact up to 14 days. | — |
Countries
Estonia, Germany, Hungary, Netherlands, Peru, United States
Outcome results
None listed