The Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis
Comparison of the Efficacy and Complication of Gentamicin and Normal Saline Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis : a Double Blind Randomized Control Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin 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 phase_4
Started Jan 2017
Typical duration for phase_4
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
First Submitted
Initial submission to the registry
October 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedAugust 20, 2018
August 1, 2018
2.5 years
October 20, 2015
August 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of sinusitis
During 1 year after treatment
Study Arms (2)
Gentamicin
ACTIVE COMPARATORGentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril
Normal saline
PLACEBO COMPARATORNormal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril
Interventions
Eligibility Criteria
You may qualify if:
- \. Chronic rhinosinusitis and/or recurrent acute/subacute sinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between December 4, 2012, and December 3, 2016
You may not qualify if:
- Patients who used antibiotic prophylaxis within 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 received IT 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
- Patient who have mental retardation
- Patient who have aminoglycosides hypersensitivity reactions
- Pregnancy women and Lactation period
- Patient who have abnormal hearing test before started gentamicin nasal irrigation
- Patient who have chronic rhinosinusitis with nasal polyp
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Pediatrics Faculty of Medicine Siriraj Hospital
Study Record Dates
First Submitted
October 20, 2015
First Posted
October 21, 2015
Study Start
January 1, 2017
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
August 20, 2018
Record last verified: 2018-08