Chronic Otitis Media Clinical Trial
Official title:
Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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