Levofloxacin in Bacterial Rhinosinussitis

NCT02712502 | Completed

• 1 other identifier: DRL_RUS/MD/2014/PMS/Levolet
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Reduction in mean value of Visual Analogue Scale after Levolet R therapy. TOLERABILITY of the treatment is assessed by the subjects using 10-point scale

  Dynamics of clinical symptoms (patient assessment) disease independently evaluate patients on a 10-point system (visual analogue scale - VAS), where: 0 - no symptom, 10 points - a symptom of painful, as you can imagine.

  10 days

Secondary Outcomes (2)

• Physician's assessment: Changes in clinical symptoms using 4-point scale

  10 days

• The final evaluation of the effectiveness of treatment on

  10 days

Study Arms (2)

Study group (OG).

50 patients c and acute exacerbation of chronic bacterial rhinosinusitis in the study group (OG). The treatment regimen in the study group. * Levofloxacin (Levolet) 750 mg (500 mg Levolet P + P Levolet 250 mg) 1 times a day. The course of treatment is 5 days. * Decongestants: xylometazoline 2 doses in each nostril two times daily - the first 5 days, then if necessary.

Drug: Levofloxacin

Control group (CG).

50 patients c and acute exacerbation of chronic rhinosinusitis in the control group (CG). The treatment regimen of the control group. Amoxicillin-Potassium Clavulanate Combination (875 mg of amoxicillin trihydrate, potassium clavulanate salt + 125 mg), 2 times a day. The course of treatment 10 days. • Decongestants: xylometazoline 2 doses in each nostril two times daily - the first 5 days, then if necessary.

Drug: Amoxicillin-Potassium Clavulanate Combination

Interventions

Levofloxacin DRUG

* Levofloxacin (Levolet) 750 mg (500 mg Levolet P + P Levolet 250 mg) 1 times a day. The course of treatment is 5 days. * Decongestants: xylometazoline 2 doses in each nostril two times daily - the first 5 days, then if necessary.

Also known as: Levolet P500, Levolet P 250

Study group (OG).

Amoxicillin-Potassium Clavulanate Combination DRUG

Amoxicillin-Potassium Clavulanate Combination (875 mg of amoxicillin trihydrate, potassium clavulanate salt + 125 mg), 2 times a day. The course of treatment 10 days. • Decongestants: xylometazoline 2 doses in each nostril two times daily - the first 5 days, then if necessary.

Also known as: Amoxiclav

Control group (CG).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 Subjects with chronic bacterial rhinosinusitis were included in study. 50 subjects with acute and aggravated chronic bacterial rhinosinusitis in the main group (subjects receiving levofloxacin (Levolet® R) 50 subjects with acute and aggravated chronic bacterial rhinosinusitis in the control group (subjects receiving levoflamoxicillin clavulanate)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Levofloxacin; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• A Y Ovchinnikov

  Head of the Department Diseases of the ear, nose and throat ,Moscow State Medical Dental University of the Ministry of Health of Russia, Otorhinolaryngology Department of Postgraduate Studies Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 18, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 18, 2016

Record last verified: 2014-11

Data Sharing

• IPD Sharing: Will not share