Comparison of ototopical antibiotic-steroid drops or oral antibiotics versus watchful waiting in children with acute tympanostomy tube otorrhea
- Conditions
- Acute tympanostomy tube otorrhea in childrenMedDRA version: 9.1Level: LLTClassification code 10033099Term: Otorrhea
- Registration Number
- EUCTR2008-005066-32-NL
- Lead Sponsor
- niversity Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
All children aged 1 to 10 years developing otorrhea after insertion of tympanostomy tubes are eligible for the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Having had tympanostomy tubes inserted within the preceding 2 weeks;
- Having used systemic or ototopical antibiotics within the preceding 2 weeks;
- Having had a period of TTO within the preceding 2 weeks;
- Having had ear discharge for more than one week;
- Known allergy to hydrocortison-bacitracine-colistine ear drops or amoxicillin-clavulanic acid;
- Down syndrome;
- Cleft palate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: What is the effectiveness of oral amoxicillin-clavulanic acid versus hydrocortison-bacitracine-colistine ear drops versus watchful waiting in children with acute otorrhea through a tympanostomy tube in terms of otoscopic signs of otorrhea, days with ear discharge, recurrent episodes of TTO, adverse effects of medication and quality of life?;Secondary Objective: What is the relation between costs and effects of these interventions?;Primary end point(s): Primary outcome measure: otoscopic signs of otorrhea at 2 weeks follow-up.<br>
- Secondary Outcome Measures
Name Time Method