N/A N=101 Randomized Triple-blind Treatment

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

Chronic Otitis Media

Bottom Line

View on ClinicalTrials.gov: NCT00189098 ↗

Enrolled (actual)

101

Serious AEs

2.0%

Results posted

Jul 2012

Primary outcome: Primary: Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear — 13; 27; 15; 23 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sulfamethoxazole-trimethoprim (Drug); Placebo (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: UMC Utrecht
Primary completion: Jun 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	13; 27; 15; 23; 11; 9	—
SECONDARY Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up	21; 26	—
SECONDARY Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up	29; 31	—
SECONDARY Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.	4; 7	—
SECONDARY Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.	23; 18	—
SECONDARY Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.	13; 11	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT00189098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.