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Completed

NCT Number: NCT00189098

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.

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Key information

Conditions

Chronic Otitis Media

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilhelmina Children Hospital, University Medical Center Utrecht

Utrecht, 3508AB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfamethoxazole-Trimethoprim

Drug

18 mg/kg, two times a day

Placebo

Drug

Primary outcomes

  1. Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear

    Time frame: 6, 12 weeks and 1 year follow-up.

    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 outcomes

  1. Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up

    Time frame: Between 6 to12 week follow up

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Dutch Health Care Insurance Board

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Jul 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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