Penicillin and Metronidazole in Treatment of Peritonsillar Abscess - Prospective, Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Participants With Recurrence of Peritonsillar Abscess
研究概览
简要总结
Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •referring doctor suspects peritonsillar abscess
- •patient is voluntary
- •patient has daily access to his/her e-mail
- •patient speaks and understands Finnish of Swedish
- •female patients have adequate birth-control method
- •patient has peritonsillar abscess
排除标准
- •allergy to penicillin
- •allergy to metronidazole
- •use of metronidazole in preceding one month
- •pregnancy
- •breast-feeding
- •renal insufficiency
- •liver insufficiency
- •alcoholism (drunk at least once a week)
- •participant in another clinical trial at the moment
- •treatment of peritonsillar abscess requires in-patient care
- •tonsillectomy during the next 30 days
- •army recruit
研究组 & 干预措施
penicillin and metronidazole
After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess
干预措施: penicillin and metronidazole in peritonsillar abscess (Drug)
penicillin and placebo
After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess
干预措施: penicillin and metronidazole in peritonsillar abscess (Drug)
结局指标
主要结局
Number of Participants With Recurrence of Peritonsillar Abscess
时间窗: 56 days
Number of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
次要结局
- Number of Participants Recovering From Peritonsillar Abscess(28 days)
研究者
Karin Blomgren
Senior Medical Officer in Charge of Research
Helsinki University Central Hospital