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

Not Applicable

• Conditions: -J159 Bacterial pneumonia, unspecified; Bacterial pneumonia, unspecified; J159

• Registration Number: PER-023-03
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-05-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified