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Effectiveness of Sulfamethoxazole-Trimethoprim in the Treatment of Chronic Otitis Media
This study is ongoing, but not recruiting participants.
Study NCT00189098   Information provided by UMC Utrecht
First Received: September 12, 2005   Last Updated: February 2, 2006   History of Changes

September 12, 2005
February 2, 2006
February 2003
 
  • Days without otorrhea at
  • T6 weeks, T3 months and T12months
Same as current
Complete list of historical versions of study NCT00189098 on ClinicalTrials.gov Archive Site
  • - otoscopy
  • - audiometry
  • - additional medical or surgical treatments
  • - side-effects
  • - quality of life
  • - costs and cost effectiveness
Same as current
 
Effectiveness of Sulfamethoxazole-Trimethoprim in the Treatment of Chronic Otitis Media
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.

 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Chronic Otitis Media
Drug: sulfamethoxazole-trimethoprim
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
110
November 2006
 

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
Both
1 Year to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00189098
 
VAZ 01-235
UMC Utrecht
Dutch Health Care Insurance Board
Study Director: Anne GM Schilder, MD, PhD University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology
UMC Utrecht
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP