Levofloxacin in Bacterial Rhinosinussitis

Rhinosinusitis Clinical Trial

— Levolet  

Official title:

Open-label Comparative Safety and Efficacy Study of Levofloxacin and Amoxicillin Clavulanic Acid in Patients With Acute ,Bacterial Rhinosinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712502
• Other study ID #: DRL_RUS/MD/2014/PMS/Levolet
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: March 14, 2016
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinosinusitis

Intervention

Drug:
• Levofloxacin
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Physician's assessment: Changes in clinical symptoms using 4-point scale	• Dynamics of clinical symptoms (score doctor) was evaluated by a doctor of 4-point scale, where "0" - the absence of symptoms, "1" - easy to severe symptoms, "2" - moderately severe symptoms, "3" - severe symptoms.	10 days	No
Secondary	The final evaluation of the effectiveness of treatment on	"Excellent" - a significant reduction of symptoms, improvement in instrumental studies; "Good" - the improvement of health, regression of symptoms, a positive trend data of laboratory and instrumental studies.; "satisfactory" - a slight improvement in the general condition and moderately positive dynamics of laboratory and instrumental studies.; "The lack of effect" - the absence of the dynamics of all symptoms, indicators of laboratory and instrumental studies, as well as when it is impossible to evaluate the effect, in the case of cessation of treatment.; "Deterioration" - weighting of the general condition and the negative dynamics of the indices of laboratory and instrumental studies, the need for additional treatment.; Tolerability independently assessed patients, 10 point system, where "0" - no side effects, "10" - the inevitable need for the drug.	10 days	No