RhinosinusitisLevoletNCT02712502
Levofloxacin in Bacterial Rhinosinussitis
An observational study of Rhinosinusitis, run by Dr. Reddy's Laboratories Limited.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- Levofloxacin and Amoxicillin-Potassium Clavulanate Combination
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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)
Who may be able to join
- 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
Who cannot join
- 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
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- Subject's inability to perceive instructions for the study procedure
- Pregnancy, lactation
- Signs of a dangerous infectious disease.
About this study
Official title: Open-label Comparative Safety and Efficacy Study of Levofloxacin and Amoxicillin Clavulanic Acid in Patients With Acute ,Bacterial Rhinosinusitis
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
Read the 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.
- Conditions
- Rhinosinusitis
- Being tested
- Levofloxacin, Amoxicillin-Potassium Clavulanate Combination
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called Levolet P500, Levolet P 250
- 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 CombinationDrug
Also called Amoxiclav
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Amoxicillin-Potassium Clavulanate Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (2)
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.
Measured: 10 days
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A Y Ovchinnikov, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712502
- Sponsor's protocol ID
- DRL_RUS/MD/2014/PMS/Levolet
- Acronym
- Levolet
- Status last verified
- Nov 2014
- First submitted
- 14 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Comparative Safety and Efficacy Study of Levofloxacin and Amoxicillin Clavulanic Acid in Patients With Acute ,Bacterial Rhinosinusitis
- ClinicalTrials.gov ID
- NCT02712502
- Acronym / sponsor ID
- Levolet / DRL_RUS/MD/2014/PMS/Levolet
- Conditions
- Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (OG). | – | Drug: Levofloxacin50 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. |
| Control group (CG). | – | Drug: Amoxicillin-Potassium Clavulanate Combination50 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinAlso: Levolet P500, Levolet P 250* 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 | Study group (OG). |
| Amoxicillin-Potassium Clavulanate CombinationAlso: AmoxiclavAmoxicillin-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 | Control group (CG). |
Primary outcome
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
Time frame: 10 days
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.
2 secondary outcomes
Physician's assessment: Changes in clinical symptoms using 4-point scale
Time frame: 10 days
The final evaluation of the effectiveness of treatment on
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Individual participant dataSharing planned: No
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A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Y Ovchinnikov principal investigator
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
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinosinusitis, run by Dr. Reddy's Laboratories Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.