ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Effectiveness of Sulfamethoxazole-Trimethoprim in the Treatment of Chronic Otitis Media

This study is ongoing, but not recruiting participants.

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   

U.S. FDA Resources

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

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

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)

Study placed in the following topic categories:
Folic Acid
Trimethoprim
Otorhinolaryngologic Diseases
Sulfamethoxazole
Otitis
Otitis Media
Trimethoprim-Sulfamethoxazole Combination
Ear Diseases

Additional relevant MeSH terms:
Antimalarials
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Renal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008




Links to all studies - primarily for crawlers