Trial record 2 of 22 for:    Schilder's Disease

Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media

This study has been completed.
Sponsor:
Collaborator:
Dutch Health Care Insurance Board
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00189098
First received: September 12, 2005
Last updated: June 8, 2012
Last verified: April 2012
  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
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:
  • Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear [ Time Frame: 6, 12 weeks and 1 year follow-up. ] [ Designated as safety issue: No ]
    The primary endpoint was otomicroscopic signs of otorrhea in either ear in the presence of a tympanostomy tube or tympanic membrane perforation at 6 and 12 weeks and 1 year follow-up. At these follow-up moments the participants were checked for the presence of otorrhea using an otomicroscope.


Secondary Outcome Measures:
  • Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up [ Time Frame: Between 6 to12 week follow up ] [ Designated as safety issue: No ]
    Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits.

  • Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up [ Time Frame: between 12 weeks to 1 year follow-up ] [ Designated as safety issue: No ]
    Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits.

  • Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up. [ Time Frame: between 6 and 12 weeks follow-up ] [ Designated as safety issue: No ]
    Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.

  • Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up. [ Time Frame: between 12 weeks and 1 year follow-up ] [ Designated as safety issue: No ]
    Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.

  • Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up. [ Time Frame: between 12 weeks and 1 year follow-up ] [ Designated as safety issue: No ]
    After 12 weeks follow-up irrespective of the presence or absence of otorrhea the study medication was discontinued. After the first 12 weeks local otorhinolaryngologists and paediatricians were free to manage symptoms of otorrhea according to their regular practice. Parents kept a diary between 12 weeks and 1 year follow-up where Ear Nose and Throat Surgery was noted. This outcome describes the number of patients who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.


Enrollment: 101
Study Start Date: February 2003
Study Completion Date: November 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: Placebo
Active Comparator: Sulfamethoxazole-trimethoprim Drug: Sulfamethoxazole-trimethoprim
18 mg/kg, two times a day

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
ClinicalTrials.gov Identifier: NCT00189098     History of Changes
Other Study ID Numbers: VAZ 01-235
Study First Received: September 12, 2005
Results First Received: April 12, 2012
Last Updated: June 8, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Ear Diseases
Otorhinolaryngologic Diseases
Otitis
Otitis Media
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014