Comparison of Two Strategies for Therapeutic Decision-making in Tuberculosis Contact Tracing: a Standard Strategy Based on Tuberculin Skin Test (TST) Alone vs TST Combined With QuantiFERON®-TB Gold In-Tube (QFT-IT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 871
- 试验地点
- 1
- 主要终点
- Development of tuberculosis.
研究概览
简要总结
Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB Gold In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study will allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis cases among contacts screened.
Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone for the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing study.
Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.
Study population: 870 subjects, household contacts of patients with culture positive pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A (standard practice), in which treatment decisions will be based on the TST result, and Arm B (experimental), in which treatment decisions will be based on the QFT result.
Interventions: participants in arm A will undergo TST; participants in arm B will undergo TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be treated with isoniazid for 6 months. All participants will be followed for two years.
End-points of evaluation: development of tuberculosis and proportion of subjects for whom treatment is prescribed in each arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Close contact of a pulmonary and/or laryngeal tuberculosis case.
- •Written informed consent.
排除标准
- •HIV infection.
- •Immunosuppression other than HIV, such as decompensated liver disease, chronic renal failure, corticosteroids treatment, malignancy under chemotherapy therapy.
- •Prior tuberculosis or positive TST.
- •Strain resistant to Isoniazid (index case).
研究组 & 干预措施
Arm A, Standard practice, TST
Participants allocated to screening as stablished by current practice (TST)
干预措施: Preventive treatment with Isoniazid. (Drug)
Arm B, Experimental, TST plus QFT-IT
Participants allocated to screening with TST, and if positive, followed by QFT-IT to confirm tuberculosis infection.
干预措施: Preventive treatment with Isoniazid (Drug)
结局指标
主要结局
Development of tuberculosis.
时间窗: Assessment of primary end-point: 24 months after randomization.
次要结局
- Prescription of treatment.(The day 0 (visit 2) after randomization.)
研究者
Miguel Santín Cerezales
PhD, MD
Hospital Universitari de Bellvitge