RhinosinusitisNCT00669799
Topical Antibiotic Use In Chronic Rhinosinusitis A Double-Blinded, Randomized, Placebo Controlled Study
A study testing gentamyacin in people with Rhinosinusitis, run by University of South Florida at 1 site in United States.
Trial summary
Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20 million Americans suffering from this diagnosis at a cost of over $4.3 billion per year. Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for antifungal irrigation has also been proposed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- gentamyacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2010
- Phase
- Interventional
- 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
Who may be able to join
- Chronic rhinosinusitis symptoms present for greater than 12 weeks.
- Two or more of the following symptoms:
- Anterior/posterior mucopurulent drainage
- Nasal obstruction
- Facial pain-pressure-fullness.
- Endoscopy shows: within the past 3months prior to entry
Show all 12Show fewer
- Discolored mucus or edema within the middle meatus or ethmoid region.
- Absence of polyps within the middle meatus.
- Evidence of rhinosinusitis on CT scan within one year of study entry
- History of prior sinus surgery with evidence of post-surgical changes on CT or clinical exam.
- History of the following labs of: CH50, mannose binding lectin, quantitative immunoglobulin A, M, E and G, and titers for tetanus, diphtheria, and Streptococcus pneumoniae antibodies. If titers for tetanus, diphtheria, and Streptococcus pneumoniae are non-protective, then immunization will be performed and antibody titers will be reevaluated. If laboratory studies have not been done prior to entry the laboratory studies will be collected and performed during or post collection of study data to rule out any data from patients with known immunodeficiencies.
- Skin prick testing will be performed at V1, unless done prior to study entry and is in the subjects medical record, for Dermatophagoides farinae, Dermatophagoides pteronyssinus, oak, bahia and bermuda grasses, cat, dog, ragweed, Alternaria, Aspergillus, American and German cockroach, and positive and negative controls.
Who cannot join
- Allergy or adverse reaction to any of the medications intended for use in the study or any related compounds.
- Receipt of systemic antibiotics for chronic rhinosinusitis within two weeks of beginning the study.
- Receipt of systemic steroids within three months of beginning the study.
- Patients using intranasal sympathomimetics or with evidence of rhinitis medicamentosa.
- Sinus surgery within three months of starting study.
- Smoking within one month of starting the study.
Show all 17Show fewer
- Pregnancy or lactation.
- Primary ciliary dyskinesia, Sjogren's syndrome, Wegener's granulomatosis, atrophic rhinitis, cystic fibrosis, history of prior sinonasal malignancy, history of sinonasal irradiation, or other illness or treatment that might affect mucociliary transport within the nasal cavity or paranasal sinuses.
- Clinically significant hepatic or renal disease.
- Complicated sinusitis (e.g. Pott's puffy tumor, sinus malignancy, osteomyelitis, abscess, etc.)
- Known immunodeficiency (including HIV, post transplant, diabetes).
- Age less than 18 years of age.
- Acute respiratory illness within 2 weeks of starting study.
- Patients who meet the criteria for chronic rhinosinusitis with nasal polyps or allergic fungal rhinosinusitis.
- Psychosocial issues that might preclude successful participation in the study.
- Concomitant Medication/Treatment
- In addition to use of the study drug or a vehicle-controlled placebo, the patient will be treated with Flonase 2 sprays each naris QD for the duration of the study. Rhinocort Aqua 4 sprays each naris QD will be substituted for patients with allergy or adverse reaction to Flonase. Augmentin 875mg PO BID will be given for 21 days beginning on the first day of the study period. Levaquin 500mg PO QD will be substituted for patients with allergy or adverse reaction to Augmentin. The patient will not use any adjunctive therapies such as oral or topical decongestants or antihistamines during the course of the study. No sinus or nasal surgery is planned during the course of the study. Patients who require additional treatment including surgery will be withdrawn from the study and considered treatment failures.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20 million Americans suffering from this diagnosis at a cost of over $4.3 billion per year. Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for antifungal irrigation has also been proposed. Topical antibiotics are used by some physicians, but there are few reports in the published literature describing their use and establishing or refuting their efficacy.
Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and tramazoline without antimicrobial; and placebo. Both of the treatment groups showed improvement over placebo, but in those groups there was no significant difference in response rates between those patients receiving neomycin and those who did not. There were no adverse events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol irrigations in the treatment of chronic rhinosinusitis.
Read more
Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are uncontrolled, retrospective studies showing improvement in symptom scores. Neither study reported any major side effects. Leonard and Bolger describe a case report and review their success with the use of topical Ceftazidime in 50 patients. Only one patient reported stinging sensation during administration. They reported no problems with antibiotic resistance.
Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and reduction of need for revision sinus surgery in patients treated with surgery followed by topical intranasal tobramycin. They report no significant side effects.
Dudley described the use of topical gentamicin in a case report of a patient with atrophic rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also describes a study by Thornell showing success with streptomycin nasal sprays and reports work by Rubinstein demonstrating safe administration of gentamicin into the nose without absorption by the nasal mucosa.
On balance, the literature describes topical antibiotics as a safe, but variably efficacious treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded, and controlled studies. The purpose of this protocol is to describe a scientifically rigorous study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis.
The patient population for this study will consist of patients who have a history of multiple sinus infections each year that require treatment with antibiotics. The patients in this study will have had recurrent infections despite prior medical and surgical intervention. They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis.
Treatment will include conventional treatment with oral antibiotics and a topical nasal steroid. In addition, patients will be randomized to receive either topical antibiotics or a vehicle placebo. The study will follow patients for a three month period.
Patients will be monitored for improvement in radiographic findings and quality of life when compared to a randomized and double-blinded placebo group. The patient population identified for inclusion in this study will also be evaluated for allergy and humoral and innate immunodeficiency. Nasal lavage will be obtained from the study population and pre and post-treatment comparisons will be performed.
Read the detailed description
Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20 million Americans suffering from this diagnosis at a cost of over $4.3 billion per year. Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for antifungal irrigation has also been proposed. Topical antibiotics are used by some physicians, but there are few reports in the published literature describing their use and establishing or refuting their efficacy.
Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and tramazoline without antimicrobial; and placebo. Both of the treatment groups showed improvement over placebo, but in those groups there was no significant difference in response rates between those patients receiving neomycin and those who did not. There were no adverse events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol irrigations in the treatment of chronic rhinosinusitis.
Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are uncontrolled, retrospective studies showing improvement in symptom scores. Neither study reported any major side effects. Leonard and Bolger describe a case report and review their success with the use of topical Ceftazidime in 50 patients. Only one patient reported stinging sensation during administration. They reported no problems with antibiotic resistance.
Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and reduction of need for revision sinus surgery in patients treated with surgery followed by topical intranasal tobramycin. They report no significant side effects.
Dudley described the use of topical gentamicin in a case report of a patient with atrophic rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also describes a study by Thornell showing success with streptomycin nasal sprays and reports work by Rubinstein demonstrating safe administration of gentamicin into the nose without absorption by the nasal mucosa.
On balance, the literature describes topical antibiotics as a safe, but variably efficacious treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded, and controlled studies. The purpose of this protocol is to describe a scientifically rigorous study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis.
The patient population for this study will consist of patients who have a history of multiple sinus infections each year that require treatment with antibiotics. The patients in this study will have had recurrent infections despite prior medical and surgical intervention. They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis.
Treatment will include conventional treatment with oral antibiotics and a topical nasal steroid. In addition, patients will be randomized to receive either topical antibiotics or a vehicle placebo. The study will follow patients for a three month period.
Patients will be monitored for improvement in radiographic findings and quality of life when compared to a randomized and double-blinded placebo group. The patient population identified for inclusion in this study will also be evaluated for allergy and humoral and innate immunodeficiency. Nasal lavage will be obtained from the study population and pre and post-treatment comparisons will be performed.
- Conditions
- Rhinosinusitis
- Being tested
- gentamyacin
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gentamyacinDrug
topical internasal
gentamyacinDrug
intranasal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | clyndamyacin Receives: Drug: gentamyacin |
| 2 | Experimental | gentamicin Receives: Drug: gentamyacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is a prospective, randomized, double-blinded, placebo-controlled clinical study designed to evaluate the efficacy of topical antibiotics in treating chronic rhinosinusitis
Measured: 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: UNABLE TO PROCEED WITH STUDY DUE TO STAFFING OF COLLABORATIVE INVESTIGATORS
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.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Lockey, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669799
- Sponsor's protocol ID
- MEIGS
- Status last verified
- May 2015
- First submitted
- 29 Apr 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Antibiotic Use In Chronic Rhinosinusitis A Double-Blinded, Randomized, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00669799
- Acronym / sponsor ID
- MEIGS
- Conditions
- Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: UNABLE TO PROCEED WITH STUDY DUE TO STAFFING OF COLLABORATIVE INVESTIGATORS
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 May 2008 (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.
Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20 million Americans suffering from this diagnosis at a cost of over $4.3 billion per year. Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for antifungal irrigation has also been proposed. Topical antibiotics are used by some physicians, but there are few reports in the published literature describing their use and establishing or refuting their efficacy.
Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and tramazoline without antimicrobial; and placebo. Both of the treatment groups showed improvement over placebo, but in those groups there was no significant difference in response rates between those patients receiving neomycin and those who did not. There were no adverse events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol irrigations in the treatment of chronic rhinosinusitis.
Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are uncontrolled, retrospective studies showing improvement in symptom scores. Neither study reported any major side effects. Leonard and Bolger describe a case report and review their success with the use of topical Ceftazidime in 50 patients. Only one patient reported stinging sensation during administration. They reported no problems with antibiotic resistance.
Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and reduction of need for revision sinus surgery in patients treated with surgery followed by topical intranasal tobramycin. They report no significant side effects.
Dudley described the use of topical gentamicin in a case report of a patient with atrophic rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also describes a study by Thornell showing success with streptomycin nasal sprays and reports work by Rubinstein demonstrating safe administration of gentamicin into the nose without absorption by the nasal mucosa.
On balance, the literature describes topical antibiotics as a safe, but variably efficacious treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded, and controlled studies. The purpose of this protocol is to describe a scientifically rigorous study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis.
The patient population for this study will consist of patients who have a history of multiple sinus infections each year that require treatment with antibiotics. The patients in this study will have had recurrent infections despite prior medical and surgical intervention. They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis.
Treatment will include conventional treatment with oral antibiotics and a topical nasal steroid. In addition, patients will be randomized to receive either topical antibiotics or a vehicle placebo. The study will follow patients for a three month period.
Patients will be monitored for improvement in radiographic findings and quality of life when compared to a randomized and double-blinded placebo group. The patient population identified for inclusion in this study will also be evaluated for allergy and humoral and innate immunodeficiency. Nasal lavage will be obtained from the study population and pre and post-treatment comparisons will be performed.
Detailed description
Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20 million Americans suffering from this diagnosis at a cost of over $4.3 billion per year. Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for antifungal irrigation has also been proposed. Topical antibiotics are used by some physicians, but there are few reports in the published literature describing their use and establishing or refuting their efficacy.
Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and tramazoline without antimicrobial; and placebo. Both of the treatment groups showed improvement over placebo, but in those groups there was no significant difference in response rates between those patients receiving neomycin and those who did not. There were no adverse events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol irrigations in the treatment of chronic rhinosinusitis.
Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are uncontrolled, retrospective studies showing improvement in symptom scores. Neither study reported any major side effects. Leonard and Bolger describe a case report and review their success with the use of topical Ceftazidime in 50 patients. Only one patient reported stinging sensation during administration. They reported no problems with antibiotic resistance.
Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and reduction of need for revision sinus surgery in patients treated with surgery followed by topical intranasal tobramycin. They report no significant side effects.
Dudley described the use of topical gentamicin in a case report of a patient with atrophic rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also describes a study by Thornell showing success with streptomycin nasal sprays and reports work by Rubinstein demonstrating safe administration of gentamicin into the nose without absorption by the nasal mucosa.
On balance, the literature describes topical antibiotics as a safe, but variably efficacious treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded, and controlled studies. The purpose of this protocol is to describe a scientifically rigorous study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis.
The patient population for this study will consist of patients who have a history of multiple sinus infections each year that require treatment with antibiotics. The patients in this study will have had recurrent infections despite prior medical and surgical intervention. They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis.
Treatment will include conventional treatment with oral antibiotics and a topical nasal steroid. In addition, patients will be randomized to receive either topical antibiotics or a vehicle placebo. The study will follow patients for a three month period.
Patients will be monitored for improvement in radiographic findings and quality of life when compared to a randomized and double-blinded placebo group. The patient population identified for inclusion in this study will also be evaluated for allergy and humoral and innate immunodeficiency. Nasal lavage will be obtained from the study population and pre and post-treatment comparisons will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: gentamyacinclyndamyacin |
| 2 | Experimental | Drug: gentamyacingentamicin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Chronic rhinosinusitis symptoms present for greater than 12 weeks.
- Two or more of the following symptoms:
- Endoscopy shows: within the past 3months prior to entry
- Evidence of rhinosinusitis on CT scan within one year of study entry
- History of prior sinus surgery with evidence of post-surgical changes on CT or clinical exam.
Key exclusion criteria (17 listed)
- Allergy or adverse reaction to any of the medications intended for use in the study or any related compounds.
- Receipt of systemic antibiotics for chronic rhinosinusitis within two weeks of beginning the study.
- Receipt of systemic steroids within three months of beginning the study.
- Patients using intranasal sympathomimetics or with evidence of rhinitis medicamentosa.
- Sinus surgery within three months of starting study.
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 |
|---|---|---|
| gentamyacintopical internasal | Drug | 1 |
| gentamyacinintranasal | Drug | 2 |
Primary outcome
This is a prospective, randomized, double-blinded, placebo-controlled clinical study designed to evaluate the efficacy of topical antibiotics in treating chronic rhinosinusitis
Time frame: 12 WEEKS
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gentamyacin in people with Rhinosinusitis, run by University of South Florida at 1 site in United States.
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 12 inclusion and 17 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: withdrawn, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
This is a prospective, randomized, double-blinded, placebo-controlled clinical study designed to evaluate the efficacy of topical antibiotics in treating chronic rhinosinusitis (time frame: 12 WEEKS). 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 28 May 2015; AzTrials last refreshed its copy on 3 Nov 2026.