PER-054-06已完成未知
A Phase II Dose-Finding Study of the Patch Test for Diagnosis of Active Tuberculosis
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
入选标准
- •1. Be between 18 and 65 years of age.
- •2. Voluntarily give written informed consent before any procedure related to the study that is not part of routine medical care.
- •Patients included in Group A must meet the following additional inclusion criteria:
- •3. Have a positive AFB smear result, for a sample taken no later than the two weeks prior to day zero (0) of the study.
- •Patients included in group C must meet the following additional inclusion criteria:
- •4. Have a positive AFB smear result, for a sample generated within the last 120 days.
- •5. Have been in treatment for TB for a period of between 30 and 90 days.
排除标准
- •1. Have participated in any clinical trial, in which a research product has been administered, within 60 days prior to the start of the study.
- •2. Have participated in a clinical trial involving the MPT64 patch test, at whatever time it occurred.
- •3. Have a positive or inconclusive result of detecting HIV in the blood.
- •4. Being immunosuppressed for any reason.
- •5. Suffer a serious physical or psychiatric illness that could interfere with the completion of the procedures of this protocol.
- •Those who meet any of the following additional exclusion criteria will not be included in Group A:
- •6. Have been in the treatment against TB for more than 96 hours.
- •Those who meet any of the following additional exclusion criteria will not be included in Group B:
- •7. Have an X-ray that suggests the presence of active TB.
- •8. Those who report having been in contact with a person with active TB within the past two years.
- •9. Have been interned in the last two years.
- •10. Present signs or symptoms that suggest active TB.
- •11. Having had active TB in the past.
研究者
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