Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
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| ClinicalTrials.gov Identifier: NCT00189098 |
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Recruitment Status :
Completed
First Posted : September 16, 2005
Results First Posted : July 13, 2012
Last Update Posted : July 13, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Otitis Media | Drug: Sulfamethoxazole-trimethoprim Drug: Placebo | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 101 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media |
| Study Start Date : | February 2003 |
| Actual Primary Completion Date : | June 2006 |
| Actual Study Completion Date : | November 2006 |
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: placebo |
Drug: Placebo |
| Active Comparator: Sulfamethoxazole-trimethoprim |
Drug: Sulfamethoxazole-trimethoprim
18 mg/kg, two times a day |
- 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.
- Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up [ Time Frame: Between 6 to12 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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
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| Ages Eligible for Study: | 1 Year to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age between 1 and 12 years
- otorrhea for more than 3 months
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189098
| Netherlands | |
| Wilhelmina Children Hospital, University Medical Center Utrecht | |
| Utrecht, Netherlands, 3508AB | |
| Study Director: | Anne GM Schilder, MD, PhD | University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00189098 |
| Other Study ID Numbers: |
VAZ 01-235 |
| First Posted: | September 16, 2005 Key Record Dates |
| Results First Posted: | July 13, 2012 |
| Last Update Posted: | July 13, 2012 |
| Last Verified: | April 2012 |
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