Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
1 other identifier
observational
40
1 country
1
Brief Summary
The propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 5, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 18, 2015
September 1, 2015
10 months
September 5, 2011
September 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of sinusitis
1 year
Secondary Outcomes (2)
Complications of gentamicin nasal irrigation usage
1 year
Frequency of antibiotic usage
1 year
Eligibility Criteria
pediatric allergy clinic in siriraj hospital
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Related Publications (3)
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.
PMID: 17844873BACKGROUNDDesrosiers 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.
PMID: 11555764BACKGROUNDUren 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.
PMID: 18545212BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Nualanong Visitsunthorn, professor
Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 5, 2011
First Posted
September 7, 2011
Study Start
March 1, 2011
Primary Completion
January 1, 2012
Study Completion
March 1, 2012
Last Updated
September 18, 2015
Record last verified: 2015-09