Levofloxacin in Bacterial Rhinosinussitis

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Inflammatory paranasal diseases are among the most common diseases in ENT In Russia, puncture method has been conventional approach to treatment of maxillary sinusitis. However, this procedure is associated with a number of drawbacks A promising trend for the treatment of purulent sinusitis is a reasonable antibacterial therapy Fluoroquinolones, particularly levofloxacin, are highly active against pneumonocci and are more active vs. the drug products of the second generation against intracellular agents (Chlamydia spp., Mycoplasma spp., M. tuberculosis, rapidly growing atypical mycobacteria (M. avium, etc.).

Due to high activity against the agents causing bacterial upper and lower respiratory tract infections they are sometimes called "respiratory" fluoroquinolones

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acid; Clavulanic Acids; Ephedrine; Levofloxacin; Nasal Decongestants; Ofloxacin; Pseudoephedrine; Xylometazoline

Criteria

Inclusion Criteria:

• Signed informed consent form.

• Males and females aged 18-60 years old

• Hospitalized subjects with verified diagnosis of moderate/severe acute bacterial rhinosinusitis

• Readiness to comply with medical recommendations.

• Assessment of objective and subjective symptoms of the disease >= 3 points

Exclusion Criteria:

• Previous nasal surgery within the last 6 months

• Participation in other studies

• Polypous rhinosinusitis

• Concomitant therapy affecting the study results (psychotropic drugs, alpha-adrenoreceptor antagonists, antihistamine drug, antibiotics, cromones, corticosteroids) within the last month

• Need in cromones, antihistamine drugs, corticosteroids (moderate and severe allergic rhinitis)

• Severe somatic diseases in the past medical history: severe endocrine pathologies, severe cardiovascular diseases, renal and/or hepatic failure, oncology

• Subject's inability to perceive instructions for the study procedure

• Pregnancy, lactation

• Signs of a dangerous infectious disease.