NCT00189098

Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Otitis Media

Interventions

Type	Name	Description
DRUG	Sulfamethoxazole-trimethoprim	18 mg/kg, two times a day
DRUG	Placebo

Timeline

• Start date: 2003-02-01
• Primary completion: 2006-06-01
• Completion: 2006-11-01
• First posted: 2005-09-16
• Last updated: 2012-07-13
• Results posted: 2012-07-13

Locations

1 site across 1 country: Netherlands