PER-016-09已完成未知
STUDY OF EFFECTIVENESS AND TOLERABILITY OF ISONIAZIDE / RIFAPENTIN ONCE A WEEK FOR THREE MONTHS VERSUS ISONIAZIDE DAILY FOR NINE MONTHS FOR THE TREATMENT OF A LATENT INFECTION WITH TUBERCULOSIS
Institutos Nacionales de Salud (NIH, siglas en ingles) de los Estados Unidos de America,0 个研究点目标入组 32 人开始时间: 2009年8月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 32
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
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •Children 2 -11 years of age and people infected with HIV> 2 years of age
- •People reactive to the Tuberculin dermoreaction test (PPD) with a high risk of developing TB without evidence of active TB. A high-risk reactive person is defined as:
- •1. Household members and other close contacts of people with confirmed TB culture who are TST-positive as part of a contact investigation within two years of the enrollment date. A close contact is defined as one with> 4 hours in a shared airspace, for a period of one week. Among the close contacts, a positive TST is defined as one with> 5 mm of induration after 5 UT of PPD placed intradermically using the Mantoux technique.
- •2. TST converters - which converted from documented negative to a positive TST within a period of two years. It is defined as a person with a Tuberculin dermal test> 10 mm within two years after a non-reactive test or a person with an increase of> 10 mm within a period of two years.
- •3. HIV seropositive people, positive TST (> 5 mm induration).
- •4. People with> 2 cm * of parenchymal pulmonary fibrosis on chest radiography, no previous history of TB treatment,> 5 mm of induration in TST, and 3 sputum cultures negative for M. tuberculosis in the final report.
- •5. Children> 2 but <5 years of age with> 10 mm induration in TST, regardless of the history of TB exposure.
- •Close HIV-seropositive contacts of people with culture-confirmed TB, regardless of the condition of TST. In addition, close HIV-seropositive contacts of people with culture-confirmed TB who have a documented history of having completed a course of treatment suitable for active TB infection or latent TB are also eligible.
- •Children> 2 but <5 years of age with a negative initial TST who are close contacts of a culture-confirmed case of TB.
- •Desire to provide signed informed consent, or parental consent and participant acceptance.
排除标准
- •Current TB confirmed with culture-positive or by clinical criteria
- •Suspicion of TB (as defined by the site researcher) or Isoniazid or rifampicin resistant tuberculosis in the source case
- •A history of treatment for> 14 consecutive days with a rifamycin or> 30 consecutive days with INH during the previous 2 years.
- •A documented history of having completed a course of treatment suitable for active TB or latent TB infection in a person who is HIV-seronegative.
- •History of susceptibility / intolerance to isoniazid or rifamycins.
- •Serum aspartate aminotransferase (AST, SGOT)> 5x the upper normal limit between people who were determined AST.
- •Pregnant or lactating women.
- •People who currently receive or plan to receive anti-retroviral therapy (eg, HIV 1 protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, CCR5 inhibitors or integrase inhibitors) in the first 90 days after enrollment.
- •Weight <10.0 kilograms
研究者
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