Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189098
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2005-09-12
Brief Title:
Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic suppurative otitis media is one of the most common chronic infections in children worldwide Symptoms include otorrhea otalgia and hearing loss In many countries it is treated primarily with antibiotics in other countries such as the Netherlands a surgical approach such as a tonsillectomy adenoidectomy placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred There is however no agreement on the management of this disease
The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media and otorrhea
The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media and otorrhea
Detailed Description:
Chronic suppurative otitis media is one of the most common chronic infections in children worldwide Symptoms include otorrhea otalgia and hearing loss In many countries it is treated primarily with antibiotics in other countries such as the Netherlands a surgical approach such as a tonsillectomy adenoidectomy placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred There is however no agreement on the management of this disease
Co-trimoxazole is an inexpensive antibiotic and tolerated well by children also when long treatment regimens or prophylaxis is necessary A previously performed retrospective study of 48 children who were referred to the pediatric department of otorhinolaryngology in the UMC Utrecht because of therapeutic resistant otorrhea showed promising results after 3 months follow-up 52 of the patients were otorrhea free 25 had otorrhea incidentally and 23 showed no signs of improvement Therefore the treatment of chronic otitis media with sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good alternative to surgical treatment
The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and otorrhea for more than 12 weeks
Co-trimoxazole is an inexpensive antibiotic and tolerated well by children also when long treatment regimens or prophylaxis is necessary A previously performed retrospective study of 48 children who were referred to the pediatric department of otorhinolaryngology in the UMC Utrecht because of therapeutic resistant otorrhea showed promising results after 3 months follow-up 52 of the patients were otorrhea free 25 had otorrhea incidentally and 23 showed no signs of improvement Therefore the treatment of chronic otitis media with sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good alternative to surgical treatment
The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and otorrhea for more than 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None