CTRI/2024/09/074020尚未招募不适用
Prevent TB among household contacts of fluoroquinolone resistant drug resistant TB patients in Mumbai
BMC(NTEP)1 个研究点 分布在 1 个国家目标入组 3,313 人开始时间: 2024年10月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,313
- 试验地点
- 1
- 主要终点
- Incidence of TB among the participants
研究概览
简要总结
This study is a non randomized single arm interventional study To determine the usefulness of Delamanid DLM as tuberculosis preventive treatment TPT for household contacts of fluoroquinolone resistant pulmonary drug resistant adult tuberculosis patients in five districts of Mumbai. This study will provide evidence on the feasibility of DLM in preventing TB among HHCs of DR TB patients in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Adults greater than 18 years and children aged greater than 5 years HHCs.
- •All HHCs of an index bacteriologically phenotype or genotype confirmed DR TB patients resistant to FQ.
- •Willing for study procedures.
- •Willing to provide written informed consent, adults greater than 18years and assent for children aged greater than 6years.
排除标准
- •Critically ill
- •Unable to take oral medications
- •Body weight lesser than 16 Kg
- •Current smear or GeneXpert or LPA or culture confirmed or clinically diagnosed Pulmonary or Extra pulmonary TB
- •Currently receiving anti TB treatment
- •Past AntiTB treatment at any time for more than 1 month during 1 year prior to enrolment
- •All HHCs of an index bacteriologically phenotype or genotype confirmed FQ resistant DR TB patients with Mtb resistant to Delamanid by tNGS or pDST.
- •Participants with abnormal chest X ray that cannot be excluded from having TB disease
- •Alcohol or substance use or dependence
- •Significant cardiac arrhythmia requiring medication
- •Study participants who have QTcF interval on ECG more than 450 m sec at screening.
- •Females who have a positive pregnancy test at screening or already known to be pregnant, breast feeding, or planning to conceive a child during the study or within 6 months of cessation of treatment. Males planning to conceive a child during the study or within 6 months of cessation of treatment.
- •Study participants with the following laboratory values as defined by the enhanced Division of Microbiology and Infectious Disease DMID adult toxicity table November 2007 at screening will be excluded labs may be repeated In the absence of clinical symptoms if a. Aspartate aminotransferase AST greater than or equal to 5.0 ULN b. Alanine aminotransferase ALT than or equal5.0 ULN. c. Total bilirubin than or equal 1.2 ULN.
- •In the presence of Clinical symptoms if a. Aspartate aminotransferase AST than or equal 3.0 ULN b. Alanine aminotransferase ALT than or equal 3.0 ULN. c. Total bilirubin than or equal ULN.
- •Any condition in the investigators opinion where participation in the study would compromise the well being of study participant or prevent, limit or confound protocol specified assessments
- •Evidence or History of known drug allergy.
结局指标
主要结局
Incidence of TB among the participants
时间窗: 12 months
次要结局
- 1. Proportion of participants having TBI 12months(2. Proportion of participants who were initiated on TPT 12 months)
研究者
Dr Daksha Shah PI
Brihanmumbai Municipal Corporation (BMC)
研究点 (1)
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