Chronic SinusitisNCT01430026
Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
An observational study of Chronic Sinusitis, run by Mahidol University at 1 site in Thailand.
Trial summary
The propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Sinusitis
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2011to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pediatric allergy clinic in siriraj hospital
Who may be able to join
- Chronic rhinosinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between January 1, 2005, and February 28, 2011
- Gentamicin nasal irrigation usage for longer than 3 months
Who cannot join
- Patients who used azithromycin prophylaxis within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
The propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis
Read the detailed description
Chronic rhinosinusitis (CRS) is characterized by symptoms > 12 weeks
Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip):
- facial pain/pressure
- reduction or loss of smell)
Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis
In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no studies in gentamicin irrigation in chronic rhinosinusitis. The aims of this study are to evaluate:
- Efficacy of gentamicin nasal irrigation in chronic rhinosinusitis (outcomes: frequency of sinusitis, frequency of antibiotic usage)
- Complication of gentamicin nasal irrigation usage
- Conditions
- Chronic Sinusitis
- Keywords
- chronic sinusitis, gentamicin nasal irrigation
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of sinusitis
Measured: 1 year
Secondary outcomes (2)
Complications of gentamicin nasal irrigation usage
Measured: 1 year
Frequency of antibiotic usage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Nualanong Visitsunthorn, professor, Principal investigator, Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430026
- Sponsor's protocol ID
- 004/2554(EC3)
- Status last verified
- Sep 2015
- First submitted
- 5 Sep 2011
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fokkens W, Lund V, Mullol J; European Position Paper on Rhinosinusitis and Nasal Polyps group. European position paper on rhinosinusitis and nasal polyps 2007. Rhinol Suppl. 2007;20:1-136.
PubMed 17844873Desrosiers MY, Salas-Prato M. Treatment of chronic rhinosinusitis refractory to other treatments with topical antibiotic therapy delivered by means of a large-particle nebulizer: results of a controlled trial. Otolaryngol Head Neck Surg. 2001 Sep;125(3):265-9. doi: 10.1067/mhn.2001.117410.
PubMed 11555764Uren B, Psaltis A, Wormald PJ. Nasal lavage with mupirocin for the treatment of surgically recalcitrant chronic rhinosinusitis. Laryngoscope. 2008 Sep;118(9):1677-80. doi: 10.1097/MLG.0b013e31817aec47.
PubMed 18545212
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT01430026
- Acronym / sponsor ID
- 004/2554(EC3)
- Conditions
- Chronic Sinusitis
- Keywords
- chronic sinusitis, gentamicin nasal irrigation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Sep 2011 (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.
The propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis
Detailed description
Chronic rhinosinusitis (CRS) is characterized by symptoms > 12 weeks
Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip):
- facial pain/pressure
- reduction or loss of smell)
Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis
In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no studies in gentamicin irrigation in chronic rhinosinusitis. The aims of this study are to evaluate:
- Efficacy of gentamicin nasal irrigation in chronic rhinosinusitis (outcomes: frequency of sinusitis, frequency of antibiotic usage)
- Complication of gentamicin nasal irrigation usage
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pediatric allergy clinic in siriraj hospital
Key inclusion criteria (2 listed)
- Chronic rhinosinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between January 1, 2005, and February 28, 2011
- Gentamicin nasal irrigation usage for longer than 3 months
Key exclusion criteria (4 listed)
- Patients who used azithromycin prophylaxis within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
- Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of sinusitis
Time frame: 1 year
2 secondary outcomes
Complications of gentamicin nasal irrigation usage
Time frame: 1 year
Frequency of antibiotic usage
Time frame: 1 year
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 Sep 2015.
- Background: PubMed 17844873Fokkens W, Lund V, Mullol J; European Position Paper on Rhinosinusitis and Nasal Polyps group. European position paper on rhinosinusitis and nasal polyps 2007. Rhinol Suppl. 2007;20:1-136.
- Background: PubMed 11555764Desrosiers MY, Salas-Prato M. Treatment of chronic rhinosinusitis refractory to other treatments with topical antibiotic therapy delivered by means of a large-particle nebulizer: results of a controlled trial. Otolaryngol Head Neck Surg. 2001 Sep;125(3):265-9. doi: 10.1067/mhn.2001.117410.
- Background: PubMed 18545212Uren B, Psaltis A, Wormald PJ. Nasal lavage with mupirocin for the treatment of surgically recalcitrant chronic rhinosinusitis. Laryngoscope. 2008 Sep;118(9):1677-80. doi: 10.1097/MLG.0b013e31817aec47.
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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.
Nualanong Visitsunthorn, professor principal investigator
Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Sinusitis, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 4 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 Sep 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 Thailand. 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 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?
Frequency of sinusitis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01430026, which also lists 3 linked publications.
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 Sep 2015.