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

UMC Utrecht

Status: Completed

Conditions: Chronic Otitis Media

Treatments: Drug: Placebo; Drug: Sulfamethoxazole-trimethoprim

Study type: Interventional

Funder types: Other

Identifiers

NCT00189098

VAZ 01-235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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101 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Sulfamethoxazole-trimethoprim

Active Comparator group

Treatment:

Drug: Sulfamethoxazole-trimethoprim