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

NCT00189098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2012-07-13

Study results available
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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.

Conditions

  • Chronic Otitis Media

Interventions

DRUG

Sulfamethoxazole-trimethoprim

18 mg/kg, two times a day

DRUG

Placebo

Sponsors & Collaborators

  • Dutch Health Care Insurance Board

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Anne GM Schilder, MD, PhD · University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2006-06-30
Completion
2006-11-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00189098 on ClinicalTrials.gov