ISRCTN19325889已完成不适用
Single-investigator, randomized, double-blind, placebo-controlled trial of the efficacy and safety of oral antibiotics versus placebo in recurrent seropositive and seronegative Lyme disease
yme Disease Practice and Research (USA)0 个研究点目标入组 216 人开始时间: 2006年3月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 18 years or older to include the elderly
- •2. Both sexes
- •3. Outpatients
- •4. A signed consent must be obtained
- •5. Diagnostic criteria: Lyme disease symptomology as described by Logigian et al
排除标准
- •1. Signs: erythema migrans or physical sign (arthritis, Bell?s palsy, heart block, or meningitis) require treatment and therefore cannot be placed into a placebo arm
- •2. Inadequate initial treatment: patients not previously treated with at least 21 consecutive days with an antibiotic known to be effective for Lyme disease
- •3. Patients without any clinical evidence of Lyme disease
- •4. Patients anticipated to not able to return for follow-up examination
- •5. Patients with a type 1 hypersensitivity to penicillins
- •6. Pregnancy and postpartum or lactating female who is nursing
- •7. Other antibiotics: anticipated requirement of systemic antibiotics other than the study medication
- •8. Initial treatment failure: patients cannot be enrolled in the re-treatment subgroup if failing the first treatment
- •9. Medication failure: patients cannot be enrolled if they have a history of failing study medication
研究者
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