Chronic Otitis MediaNCT00189098
Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
A study testing Sulfamethoxazole-trimethoprim in people with Chronic Otitis Media, run by UMC Utrecht at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Chronic Otitis Media
- What is being tested?
- Sulfamethoxazole-trimethoprim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2003to Nov 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 1 and 12 years
- otorrhea for more than 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wilhelmina Children Hospital, University Medical Center Utrecht
Utrecht, Utrecht, 3508AB
About this study
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.
Read the detailed description
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.
Co-trimoxazole is an inexpensive antibiotic and tolerated well by children, also when long treatment regimens or prophylaxis is necessary. A previously performed retrospective study of 48 children who were referred to the pediatric department of otorhinolaryngology in the UMC Utrecht because of "therapeutic resistant" otorrhea showed promising results; after 3 months follow-up, 52% of the patients were otorrhea free, 25% had otorrhea incidentally and 23% showed no signs of improvement. Therefore, the treatment of chronic otitis media with sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good alternative to surgical treatment.
The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and otorrhea for more than 12 weeks.
- Conditions
- Chronic Otitis Media
- Being tested
- Sulfamethoxazole-trimethoprim, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfamethoxazole-trimethoprimDrug
18 mg/kg, two times a day
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Sulfamethoxazole-trimethoprim | Active comparator | Not described Receives: Drug: Sulfamethoxazole-trimethoprim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits.
Measured: Between 6 to12 week follow up
Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up
Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits.
Measured: 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.
Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.
Measured: 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.
Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.
Measured: 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.
After 12 weeks follow-up irrespective of the presence or absence of otorrhea the study medication was discontinued. After the first 12 weeks local otorhinolaryngologists and paediatricians were free to manage symptoms of otorrhea according to their regular practice. Parents kept a diary between 12 weeks and 1 year follow-up where Ear Nose and Throat Surgery was noted. This outcome describes the number of patients who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.
Measured: between 12 weeks and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionJun 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Otitis MediaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Health Care Insurance Board
- Investigators
- Anne GM Schilder, MD, PhD, Study director, University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189098
- Sponsor's protocol ID
- VAZ 01-235
- Status last verified
- Apr 2012
- First submitted
- 12 Sep 2005
- Last updated
- 13 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 17473089van 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.
PubMed 19297377
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
- ClinicalTrials.gov ID
- NCT00189098
- Acronym / sponsor ID
- VAZ 01-235
- Conditions
- Chronic Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Health Care Insurance Board
- Study start
- Feb 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 13 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Co-trimoxazole is an inexpensive antibiotic and tolerated well by children, also when long treatment regimens or prophylaxis is necessary. A previously performed retrospective study of 48 children who were referred to the pediatric department of otorhinolaryngology in the UMC Utrecht because of "therapeutic resistant" otorrhea showed promising results; after 3 months follow-up, 52% of the patients were otorrhea free, 25% had otorrhea incidentally and 23% showed no signs of improvement. Therefore, the treatment of chronic otitis media with sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good alternative to surgical treatment.
The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and otorrhea for more than 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo |
| Sulfamethoxazole-trimethoprim | Active comparator | Drug: Sulfamethoxazole-trimethoprim |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age between 1 and 12 years
- otorrhea for more than 3 months
Key exclusion criteria (8 listed)
- cholesteatoma
- known immune deficiency other than IgA or IgG2
- Down's syndrome
- craniofacial anomalies
- cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfamethoxazole-trimethoprim18 mg/kg, two times a day | Drug | Sulfamethoxazole-trimethoprim |
| Placebo | Drug | placebo |
Primary outcome
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear
Time frame: 6, 12 weeks and 1 year follow-up.
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.
5 secondary outcomes
Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up
Time frame: Between 6 to12 week follow up
Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: between 12 weeks and 1 year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17473089van 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.
- Derived from this study: PubMed 19297377van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne GM Schilder, MD, PhD study director
University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulfamethoxazole-trimethoprim in people with Chronic Otitis Media, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear (time frame: 6, 12 weeks and 1 year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00189098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.