COMPARATIVE, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-MASKED STUDY OF AZITROMYCIN SR VERSUS LEVOFLOXACIN FOR THE TREATMENT OF PNEUMONIA ACQUIRED IN THE MILD TO MODERATE COMMUNITY IN ADULTS

PFIZER S.A.,0 个研究点目标入组 0 人开始时间: 2003年5月18日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Written informed consent of the patient or a legal representative.
•2. Men or women, from the age of 18, with ambulatory oral therapy
•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.

•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
•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.

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