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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 |
| 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
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 | |
| Study Director: | Anne GM Schilder, MD, PhD | University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology |
More Information
| Study ID Numbers: | VAZ 01-235 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00189098 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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Trimethoprim Otorhinolaryngologic Diseases Sulfamethoxazole Otitis Media Folate Trimethoprim-Sulfamethoxazole Combination Anti-Infective Agents, Urinary |
Folic Acid Antagonists Folinic Acid Ear Diseases Vitamin B9 Folic Acid Antimalarials Otitis |
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Anti-Infective Agents Antiprotozoal Agents Trimethoprim Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Sulfamethoxazole Otitis Media Enzyme Inhibitors Trimethoprim-Sulfamethoxazole Combination |
Anti-Infective Agents, Urinary Folic Acid Antagonists Renal Agents Ear Diseases Pharmacologic Actions Antimalarials Antiparasitic Agents Otitis Therapeutic Uses |