Levofloxacin in Bacterial Rhinosinussitis
Condition: Rhinosinusitis
MeSH terms: Sinusitis
Study type: Observational

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
    

Detailed description: 
      Inflammatory diseases of paranasal sinuses occupy one of the leading positions in the overall
      structure of ENT-diseases.

      Puncture method has been a conventional approach to the treatment of suppurative maxillary
      sinusitis in Russia until present. However, this relatively simple and conventional treatment
      method has a number of disadvantages. Fear of an unpleasant procedure is justified.
      Generally, single puncture does not ensure healing, and the doctor has to install drainage or
      of perform repeated manipulations significantly reducing quality of life during the disease
      period. There is also a certain risk of puncture needle penetration into adjacent areas.
      Sometimes direct contraindications to punctures exist (intolerance of topical anesthetics,
      blood clotting disorders, etc.).

      The puncture itself, as an independent method, is a relieving procedure rather than a
      pathognomonic treatment method, especially regarding severe combined forms of sinusitis with
      risk of intracranial complications. Due to lacking standardized antibacterial drugs to be
      injected into the sinus, multiple punctures are erroneously considered to be able of
      eliminating the bacterial agent successfully.

      One of the promising trends regarding the treatment of suppurative maxillary sinusitis is an
      adequate antibacterial therapy. Fluoroquinolones of last generations, levofloxacin in
      particular, which are highly active against pneumococci, are more effective vs. generation II
      drugs against intracellular agents (Chlamydia spp., Mycoplasma spp., M.tuberculosis, rapidly
      growing atypical mycobacteria (M.avium, etc.). At that activity towards other gram-negative
      bacteria is not reduced. An important property of these drugs consists in activity regarding
      a number of bacteria resistant to generation II fluoroquinolones. Due to high activity
      against the agents of upper and lower respiratory bacterial infections they are sometimes
      called "respiratory" fluoroquinolones.

      According to a publication, Levofloxacin 500 mg q.d. for 5 days eliminated radiological signs
      of the disease by the end of the course in 65% subjects, while 35% showed positive changes
      only (М.А. Panyakina, 2012). Based on these findings, otolaryngologists have to obtain higher
      therapeutic efficacy levels with the same 5-day course, since this treatment term
      demonstrates violated compliance most frequently. One of the options is an elevation of daily
      dose. In particular, Rameez Shah (2013) published data concerning high efficacy of
      levofloxacin at a daily dose of 750 mg for 5 days.

      Necessity to search ways to shorten the current course of antibiotic therapy is being under
      discussion at all levels. Particularly, 24th European Congress of Clinical Microbiology and
      Infectious Diseases performed on May 10-13, 2014 in Barcelona (ECCMID 2014) repeatedly raised
      question concerning revision of the current treatment standards and clinical recommendations
      concerning duration of antibiotic therapy and dosing regimens.

      Based on the above-mentioned findings, it would be interesting to evaluate efficacy of
      various antibiotic schemes (respiratory fluoroquinolones or protected aminopenicillin) in
      hospital conditions.
    

Intervention name(s): Levofloxacin; Amoxicillin-Potassium Clavulanate Combination
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Levolet P500, Levolet P 250; Amoxiclav
Intervention MeSH terms: Amoxicillin; Levofloxacin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Observational model: Case-Control
Time perspective: Prospective
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)