Tick Borne Diseases in Norwegian General Practice. A Randomized, Controlled Trial for Treatment of Erythema Migrans in Norwegian General Practice. A Comparison of Phenoxymethylpenicillin, Amoxicillin and Doxycycline.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Duration of Erythema migrans (EM)
研究概览
简要总结
Tick borne diseases are increasing in Norway. Lyme borreliosis is the most common infection. Erythema migrans is mainly diagnosed and treated in general practice. There is disagreement about what antibiotic treatment that should be given. An RCT with the three most common antibiotics used, will support data for revision of national guidelines.
详细描述
Comparison of phenoxymethylpenicillin, doxycycline and amoxicillin for Erythema migrans in Norwegian general practice. Every patient receives 14 days of antibiotic treatment. There are blood samples for measurement of Borrelia antibody level at day 1, 14 and 90 and questionnaires on subjective health complaints (SHC) at day 1, 90 and 360. Side symptoms and side effects are registered. For volunteers there is an additional PCR-analysis on punch biopsy from the EM for subgrouping of the Borrelia bacteria. TBE-antibodies are measured on day 14. Antibody levels and SHC-scores are compared to healthy blood donors.
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 (Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of Erythema migrans
- •Over the age of 18
- •Signing an concent form after information in writing
排除标准
- •Allergic to any of the three drugs in the study
- •Under the age of 18
- •Pregnancy
- •Dementia or known drug abuse
- •Antibiotic treatment last 14 days
- •Concommitant Chemotherapy or immunomodulating therapy
- •Concommitant use of medicine with potential interaction (defined in protocol)
研究组 & 干预措施
Doxycycline
Doxycycline, 100 mg, tablets, b.i.d., 14 days
干预措施: Doxycycline (Drug)
Penicillin
Phenoxymethylpenicillin tablets 650 mg. 2 tablets t.i.d. 14 days
干预措施: Phenoxymethylpenicillin (Drug)
Amoxicillin
Amoxicillin 500 mg capsula, t.i.d., 14 days
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Duration of Erythema migrans (EM)
时间窗: 1-90 days
On day 1 duration until first the consulation is registered. Day 1-14 the EM is registered in a patient diary. On day 14 the doctor is asked whether the EM has disseapeared. If not the patient is followed by phone from the researchers. On day 90 they are additionally asked for how long it lasted.
次要结局
- Side symptoms(1-14 days)
- Borrelia antibodies(1-90 days)
- Subjective Health Complaints (SHC)(1 year)
- Side effects(1-14 days)
- Subgrouping and TBE(1-14 days)
研究者
Morten Lindbaek
Professor
University of Oslo