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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University
ClinicalTrials.gov Identifier:
NCT02582099
First received: October 20, 2015
Last updated: May 2, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
Rhinosinusitis
Drug: Gentamicin nasal irrigation
Drug: Normal saline nasal irrigation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Frequency of sinusitis [ Time Frame: During 1 year after treatment ]

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02582099

Contacts
Contact: Nualanong Visitsunthorn, Professor +6624195670 nualanongv@yahoo.com

Locations
Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Nualanong Visitsunthorn, prof    (662)4197000 ext 5941    sinvs@mahidol.ac.th   
Principal Investigator: Nualanong Visitsunthorn, Prof         
Sponsors and Collaborators
Mahidol University
  More Information

Responsible Party: Nualanong Visitsunthorn, Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT02582099     History of Changes
Other Study ID Numbers: 271/2555(EC1)
Study First Received: October 20, 2015
Last Updated: May 2, 2016

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017