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| Sponsors and Collaborators: |
UMC Utrecht Dutch Health Care Insurance Board |
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00189098 |
Purpose
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.
| Condition | Intervention |
|
Chronic Otitis Media |
Drug: sulfamethoxazole-trimethoprim |
| MedlinePlus related topics: | Ear Infections Tonsils and Adenoids |
| ChemIDplus related topics: | Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effectiveness of Sulfamethoxazole-Trimethoprim in the Treatment of Chronic Otitis Media |
| Estimated Enrollment: | 110 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | November 2006 |
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.
Eligibility
| Ages Eligible for Study: | 1 Year to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |||||
| Wilhelmina Children Hospital, University Medical Center Utrecht | |||||
| Utrecht, Netherlands, 3508AB | |||||
| UMC Utrecht |
| Dutch Health Care Insurance Board |
| Study Director: | Anne GM Schilder, MD, PhD | University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology |
More Information
| Study ID Numbers: | VAZ 01-235 |
| First Received: | September 12, 2005 |
| Last Updated: | February 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00189098 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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