Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
Information source: UMC Utrecht
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Otitis Media
Intervention: Sulfamethoxazole-trimethoprim (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: UMC Utrecht Official(s) and/or principal investigator(s): Anne GM Schilder, MD, PhD, Study Director, Affiliation: University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology
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.
Clinical Details
Official title: Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear
Secondary outcome: Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-upNumber of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up. Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up. Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.
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.
Eligibility
Minimum age: 1 Year.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age between 1 and 12 years
- otorrhea for more than 3 months
Exclusion Criteria:
- cholesteatoma
- known immune deficiency other than IgA or IgG2
- Down's syndrome
- craniofacial anomalies
- cystic fibrosis
- immotile cilia syndrome
- allergy to sulfamethoxazole-trimethoprim
- continuous use of sulfamethoxazole-trimethoprim for more than six weeks in the past
six months
Locations and Contacts
Wilhelmina Children Hospital, University Medical Center Utrecht, Utrecht 3508AB, Netherlands
Additional Information
Starting date: February 2003
Last updated: June 8, 2012
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