Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 1 and 12 years
- •otorrhea for more than 3 months
排除标准
- •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
研究组 & 干预措施
placebo
干预措施: Placebo (Drug)
Sulfamethoxazole-trimethoprim
干预措施: Sulfamethoxazole-trimethoprim (Drug)
结局指标
主要结局
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear
时间窗: 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.
次要结局
- Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up(Between 6 to12 week follow up)
- Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up(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.(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.(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.(between 12 weeks and 1 year follow-up)