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

Condition(s) targeted: Chronic Otitis Media

Intervention: sulfamethoxazole-trimethoprim (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: UMC Utrecht

Official(s) and/or principal investigator(s):
Anne GM Schilder, MD, PhD, Study Director, Affiliation: University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology

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.

Official title: Effectiveness of Sulfamethoxazole-Trimethoprim in the Treatment of Chronic Otitis Media

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Days without otorrhea at

T6 weeks, T3 months and T12months

Secondary outcome:

- otoscopy

- audiometry

- additional medical or surgical treatments

- side-effects

- quality of life

- costs and cost effectiveness

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.

Minimum age: 1 Year. Maximum age: 12 Years. Gender(s): Both.

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

Wilhelmina Children Hospital, University Medical Center Utrecht, Utrecht 3508AB, Netherlands

Starting date: February 2003
Ending date: November 2006
Last updated: February 2, 2006