Acute tympanostomy tube otorrhea in children MedDRA version: 9.1 Level: LLT Classification code 10033099 Term: Otorrhea
Conditions
Interventions
Trade Name: Bacicoline-B
Pharmaceutical Form: Ear drops*
INN or Proposed INN: BACITRACIN
CAS Number: 1405874
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number
Sponsors
University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed