None listed
Conditions
Interventions
Azithromycin 2 g Type of group
Azithromycin SR 2.0 g orally will be administered once and then placebo of Levofloxacin 500 mg once a day for 7 days.
Group name:Levofloxacin 500 mg Type of group
Levofloxacin 500 mg will be administered once a day for 7
more placebo equivalent to azithromycin 2g orally in a single dose.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent of the patient or a legal representative. 2. Men or women, from the age of 18, with ambulatory oral therapy indicated. 3. Cough that produces sputum (must be sent to the laboratory for culture and sensitivity) 4. Diagnosis of pneumonia demonstrated by two or more signs or symptoms 5. PA and lateral chest X-ray that reveals the presence of new infiltrate or consolidation that can not be attributed to a process other than nemnonia. 6. Fine Modified Risk Score <90 (Fine Class I, U and UI). 7. Women of childbearing potential must present a urine pregnancy test negative within 48 hours before the start of the study medication.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity or known or suspected intolerance to azithromycin, levofloxacin, or other macrolides or quinolones. 2. Diseases of previously diagnosed immune function. 3. Pregnant or lactating women. 4. Treatment with a systemic antibiotic greater than 1 dose or 1 combination of dose (such as cephalosporin and macrolide) within the previous 7 days, or probability of receiving other systemic antibiotics during participation in the study. 5. Gastrointestinal disorders that could affect the absorption of the drug. 6. Any medical pathology that, in the opinion of the Investigator, could interfere with the evaluation of the drug under study and / or make the patient unfit for the enrollment. 7. Pathologies previously diagnosed that tend to imitate or complicate the course and evaluation of the infectious process (eg, bronchiectasis, abscesses Pulmonary or empyema, active TB, lung malignancy, cystic fibrosis, post obstructive pneumonia). 8. Renal insufficiency known or suspected with creatine clearance calculated less than 50 mL / min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical examination, detection of S. pneumoniae antigen in urine, blood cultures, oropharyngeal swab, chest x-ray, serology for M. pneumoniae and C. p. Pneumoniae. Measure:The single dose, orally, of 2.0 g. of azithromycin SR is not clinically inferior to 7 days of 500 mg. of levofloxacin, orally, once a day for the treatment of community-acquired pneumonia, mild to moderate. Timepoints:day 3-5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Blood culture, throat swab Measure:Evaluation of bacteriological efficacy and safety for both treatment regimens. Timepoints:14-21 days | — |
Countries
Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Finland, France, Germany, India, Italy, Mexico, Panama, Peru, Spain, United States
Outcome results
None listed