CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 enrolled
Drug / intervention
Sulfamethoxazole-trimethoprim +1 moredrug
Likely dose
Sulfamethoxazole-trimethoprim 18 mg/kg orally twice dailyAI-extracted
Key inclusion· 2
  • Age between 1 and 12 years
  • Otorrhea (ear drainage) for more than 3 months
Key exclusion· 8
  • Cholesteatoma
  • Known immune deficiency other than IgA or IgG2 deficiency
  • Down syndrome
  • Craniofacial anomalies

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00189098
NCT00189098N/ACompleted

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

UMC Utrecht·interventional·Posted Sep 16, 2005·Updated Jul 13, 2012

In Brief

A clinical study evaluating Sulfamethoxazole-trimethoprim and Placebo for Chronic Otitis Media. Completed, enrolled 101 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartFeb 1, 2003
Primary CompletionJun 1, 2006
Study CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

Sulfamethoxazole-trimethoprimdrug

18 mg/kg, two times a day

Placebodrug