Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia
- Conditions
- -J189 Pneumonia, unspecifiedPneumonia, unspecifiedJ189
- Registration Number
- PER-056-06
- Lead Sponsor
- ADVANCE LIFE SCIENCE, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Clinical cure rate in the visit of the Healing Test.<br>Timepoints:Days 14-22.<br>
- Secondary Outcome Measures
Name Time Method