| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Effectiveness of Sulfamethoxazole-Trimethoprim in the Treatment of Chronic Otitis Media | ||||
| Official Title † | Effectiveness of Sulfamethoxazole-Trimethoprim in the Treatment of Chronic Otitis Media | ||||
| 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. |
||||
| 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. |
||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Days without otorrhea at T6 weeks, T3 months and T12months |
||||
| Secondary Outcome Measure † | - otoscopy - audiometry - additional medical or surgical treatments - side-effects - quality of life - costs and cost effectiveness |
||||
| Condition † | Chronic Otitis Media | ||||
| Intervention † | Drug: sulfamethoxazole-trimethoprim | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 110 | ||||
| Start Date † | February 2003 | ||||
| Completion Date | November 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 1 Year to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Netherlands | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00189098 | ||||
| Organization ID | VAZ 01-235 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | UMC Utrecht | ||||
| Collaborators †† | Dutch Health Care Insurance Board | ||||
| Investigators † |
|
||||
| Information Provided By | UMC Utrecht | ||||
| Verification Date | June 2005 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | February 2, 2006 | ||||
|
