Clinical trial NCT00189098: Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
Official title: Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Otitis Media
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Dutch Health Care Insurance Board
First posted: 2005-09-16
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear
timeFrame: 6, 12 weeks and 1 year follow-up.
Secondary outcomes:
measure: Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up
timeFrame: Between 6 to12 week follow up
measure: Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up
timeFrame: between 12 weeks to 1 year follow-up
measure: Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.
timeFrame: between 6 and 12 weeks follow-up
measure: Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.
timeFrame: between 12 weeks and 1 year follow-up
measure: Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.
timeFrame: between 12 weeks and 1 year follow-up
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Wilhelmina Children Hospital, University Medical Center Utrecht
Study officials:
affiliation: University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology
name: Anne GM Schilder, MD, PhD
role: STUDY_DIRECTOR
References:
citation: van der Veen EL, Rovers MM, Albers FW, Sanders EA, Schilder AG. Effectiveness of trimethoprim/sulfamethoxazole for children with chronic active otitis media: a randomized, placebo-controlled trial. Pediatrics. 2007 May;119(5):897-904. doi: 10.1542/peds.2006-2787.
citation: van der Veen EL, Schilder AG, Timmers TK, Rovers MM, Fluit AC, Bonten MJ, Leverstein-van Hall MA. Effect of long-term trimethoprim/sulfamethoxazole treatment on resistance and integron prevalence in the intestinal flora: a randomized, double-blind, placebo-controlled trial in children. J Antimicrob Chemother. 2009 May;63(5):1011-6. doi: 10.1093/jac/dkp050. Epub 2009 Mar 18.