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

NCT ID: NCT00189098

Last Updated: 2012-07-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Chronic Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sulfamethoxazole-trimethoprim

Group Type ACTIVE_COMPARATOR

Sulfamethoxazole-trimethoprim

Intervention Type DRUG

18 mg/kg, two times a day

Interventions

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Sulfamethoxazole-trimethoprim

18 mg/kg, two times a day

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Health Care Insurance Board

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

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Anne GM Schilder, MD, PhD

Role: STUDY_DIRECTOR

University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology

Locations

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Wilhelmina Children Hospital, University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 17473089 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19297377 (View on PubMed)

Other Identifiers

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VAZ 01-235

Identifier Type: -

Identifier Source: org_study_id