|- candidate number||4190|
|- NTR Number||NTR1481|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-okt-2008|
|- Secondary IDs||80-82310-98-09036 ZonMw|
|- Public Title||'Comparison of ototopical antibiotic-steroid drops or oral antibiotics versus watchful waiting in children with acute tympanostomy tube otorrhea'|
|- Scientific Title||'Comparison of Bacicoline-B eardrops or oral Augmentin versus watchful waiting in children with acute tympanostomy tube otorrhea'|
|- hypothesis||Current management of tympanostomy tube otorrhea includes ototopical antibiotic-steroid drops, oral antibiotics or watchful waiting. Empirical evidence regarding the cost-effectiveness of these approaches is lacking.|
|- Healt Condition(s) or Problem(s) studied||Children, Antibiotics, Tympanostomy , Otorrhea|
|- Inclusion criteria||1. All children aged 1 to 10 years developing otorrhea after insertion of tympanostomy tubes.|
|- Exclusion criteria||1. Having had tympanostomy tubes inserted within the preceding 2 weeks; |
2. Having used systemic or ototopical antibiotics within the preceding 2 weeks;
3. Having had a period of tympanostomy tube otorrhea within the preceding 2 weeks;
4. Having had ear discharge for more than one week;
5. Known allergy to hydrocortison-bacitracine-colistine ear drops or amoxicillin-clavulanic acid;
6. Down syndrome;
7. Cleft palate.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2009|
|- planned closingdate||31-jan-2012|
|- Target number of participants||315|
|- Interventions||Children whose parents have given informed consent will be randomly assigned to either:|
1) Hydrocortison-bacitracine-colistine (Bacicoline-B) ear drops (3dd 5 drops for 7 days);
Amoxicillin-clavulanic acid (30-7.5 mg/kg in 3dd to be taken orally for 7 days); 3) watchful waiting.
|- Primary outcome||- Otoscopic signs of otorrhea at the scheduled follow-up visit at 2 weeks.|
|- Secondary outcome||1. Episodes and days of otorrhea according to the parents (diary);|
2. Adverse effects of the study medication (diary);
3. Complications (diary);
4. Microbiology of the otorrhea samples;
5. Health-related quality of life (at baseline and scheduled follow-up visits);
|- Timepoints||February 2009 - January 2012; 36 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Anne G.M. Schilder|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Anne G.M. Schilder|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ), Julius Center for Health Sciences and Primary Care|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background: |
Otorrhea is the most common complication in children with tympanostomy tubes in place.
In the Netherlands, each year about 10,000 children suffer from tympanostomy tube otorrhea (TTO). It causes discomfort to the child and is a cause of concern to its parents. Current management of TTO exists of ototopical antibiotic-steroid drops, oral antibiotics or watchful waiting. Empirical evidence regarding the cost-effectiveness of these approaches is lacking.
1. What is the effectiveness of oral antibiotics versus ototopical antibiotic-steroid drops versus watchful waiting in children with acute TTO in terms of otoscopic signs of otorrhea, days with ear discharge, recurrent episodes of TTO, adverse effects, and quality of life?
2. What is the relation between costs and effects of these interventions?
Pragmatic multicenter randomized trial with a follow-up of 6 months.
315 children aged 1 to 10 years developing otorrhea as from 2 weeks after insertion of tympanostomy tubes.
1) hydrocortison-bacitracine-colistine (Bacicoline-B) ear drops (3dd 5 drops for 7 days);
2) amoxicillin-clavulanic acid (30-7.5 mg/kg in 3dd to be taken orally for 7 days); 3) watchful waiting.
Primary outcome measure:
Otoscopic signs of otorrhea at 2 weeks follow-up.
Secondary outcome measures:
Episodes and days of otorrhea, health-related quality of life, adverse effects of study medication, complications, microbiology of otorrhea samples, and cost-effectiveness.
The effects of watchful waiting versus ototopical antibiotic drops versus oral antibiotics
will be calculated as risk differences and risk ratios with 95% confidence intervals. Kaplan Meier curves for duration of ear discharge will be plotted, and differences tested with a log rank test. Quality of life data will be analyzed with analyses of variance (ANOVA). All analyses will be performed on an
Incremental cost-effectiveness ratios (iCERs) with 95% confidence intervals will be calculated, i.e. the costs for society to treat the number of patients needed to clinically cure one patient.
February 2009-January 2011; 36 months.
|- Main changes (audit trail)|
|- RECORD||6-okt-2008 - 15-okt-2008|