Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dutch Health Care Insurance Board | OTHER |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| Sulfamethoxazole-trimethoprim | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfamethoxazole-trimethoprim | Drug | 18 mg/kg, two times a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6, 12 weeks and 1 year follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between 6 to12 week follow up |
| Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne GM Schilder, MD, PhD | University Medical Centre Utrecht, Department of Pediatric Otorhinolaryngology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilhelmina Children Hospital, University Medical Center Utrecht | Utrecht | Utrecht | 3508AB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17473089 | Result | 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. | |
| 19297377 | Derived | van 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. |
Not provided
Not provided
Not provided
Patients were recruited between February 2003 and June 2006. Otorhinolaryngologists and paediatricians from all over the Netherlands referred potential participants, i.e. children with COM that had failed conventional management with topical medications and/or short term systemic antibiotics
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea. |
| FG001 | Sulfamethoxazole-trimethoprim | Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | intention to treat | Posted | Number | participants | 6, 12 weeks and 1 year follow-up. |
|
During the first 12 weeks
Using diaries
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulfamethoxazole-trimethoprim |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mastoiditis | Ear and labyrinth disorders | Systematic Assessment | Mastoiditis was measured by using the diaries and hospital admissions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting or diarrhoea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. A. Schilder | Wilhelmina Children's Hospital, University Medical Center Utrecht | 0031 302504580 | A.Schilder@umcutrecht.nl |
Not provided
| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
|
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. |
| 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. | 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. | 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. | between 12 weeks and 1 year follow-up |
| BG001 | Sulfamethoxazole-trimethoprim | Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
The children in this group received placebo orally two times a day for 6 to 12 weeks.
|
|
|
| Secondary | 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. | 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. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart. | Posted | Number | participants | Between 6 to12 week follow up |
|
|
|
|
| Secondary | 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. | 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. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart. | Posted | Number | participants | between 12 weeks to 1 year follow-up |
|
|
|
|
| Secondary | 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. | 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. Some parents did not fill in the required forms and these were excluded in this analysis. | Posted | Number | participants | between 6 and 12 weeks follow-up |
|
|
|
|
| Secondary | 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. | 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. Some parents did not fill in the required forms and these were excluded in this analysis. | Posted | Number | participants | between 12 weeks and 1 year follow-up |
|
|
|
|
| Secondary | 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. | Posted | Number | participants | between 12 weeks and 1 year follow-up |
|
|
|
|
| 1 |
| 50 |
| 4 |
| 50 |
| EG001 | Placebo | 1 | 51 | 1 | 51 |
|
| skinrash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |