Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedResults Posted
Study results publicly available
July 13, 2012
CompletedJuly 13, 2012
April 1, 2012
3.3 years
September 12, 2005
April 12, 2012
June 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear
The primary endpoint was otomicroscopic signs of otorrhea in either ear in the presence of a tympanostomy tube or tympanic membrane perforation at 6 and 12 weeks and 1 year follow-up. At these follow-up moments the participants were checked for the presence of otorrhea using an otomicroscope.
6, 12 weeks and 1 year follow-up.
Secondary Outcomes (5)
Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up
Between 6 to12 week follow up
Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up
between 12 weeks to 1 year follow-up
Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.
between 6 and 12 weeks follow-up
Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.
between 12 weeks and 1 year follow-up
Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.
between 12 weeks and 1 year follow-up
Study Arms (2)
placebo
PLACEBO COMPARATORSulfamethoxazole-trimethoprim
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age between 1 and 12 years
- otorrhea for more than 3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Dutch Health Care Insurance Boardcollaborator
Study Sites (1)
Wilhelmina Children Hospital, University Medical Center Utrecht
Utrecht, Utrecht, 3508AB, Netherlands
Related Publications (2)
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.
PMID: 17473089RESULTvan 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.
PMID: 19297377DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. A. Schilder
- Organization
- Wilhelmina Children's Hospital, University Medical Center Utrecht
Study Officials
- STUDY DIRECTOR
Anne GM Schilder, MD, PhD
University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
February 1, 2003
Primary Completion
June 1, 2006
Study Completion
November 1, 2006
Last Updated
July 13, 2012
Results First Posted
July 13, 2012
Record last verified: 2012-04