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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Days without otorrhea at
  • T6 weeks, T3 months and T12months

Secondary Outcome Measures:
  • - otoscopy
  • - audiometry
  • - additional medical or surgical treatments
  • - side-effects
  • - quality of life
  • - costs and cost effectiveness

Estimated Enrollment: 110
Study Start Date: February 2003
Estimated Study Completion Date: November 2006
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

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189098

Locations
Netherlands
Wilhelmina Children Hospital, University Medical Center Utrecht
Utrecht, Netherlands, 3508AB
Sponsors and Collaborators
UMC Utrecht
Dutch Health Care Insurance Board
Investigators
Study Director: Anne GM Schilder, MD, PhD University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology
  More Information

No publications provided

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)

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010