The Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis

• Sponsor: Mahidol University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02582099
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinosinusitis	Drug: Gentamicin nasal irrigation; Drug: Normal saline nasal irrigation	Phase 4

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. Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis. Gentamicin irrigation should be helpful in chronic rhinosinusitis.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Jun 30, 2019
• Anticipated Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gentamicin Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril	Drug: Gentamicin nasal irrigation; Nasal wash with gentamicin solution
Placebo Comparator: Normal saline Normal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril	Drug: Normal saline nasal irrigation; Nasal wash with normal saline solution

Outcome Measures

Primary Outcome Measures

1. Frequency of sinusitis [During 1 year after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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

Exclusion Criteria:

1. Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation

2. Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation

3. Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation

4. Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation

5. Patient who have mental retardation

6. Patient who have aminoglycosides hypersensitivity reactions

7. Pregnancy women and Lactation period

8. Patient who have abnormal hearing test before started gentamicin nasal irrigation

9. Patient who have chronic rhinosinusitis with nasal polyp

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nualanong Visitsunthorn, Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
• ClinicalTrials.gov Identifier: NCT02582099
• Other Study ID Numbers: 271/2555(EC1)
• First Posted: Oct 21, 2015
• Last Update Posted: Aug 20, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Sinusitis; Gentamicins

Study Results

No Results Posted as of Aug 20, 2018