Impact of Nutritional Support for Tuberculosis on Intermediate and Terminal Undernutrition and Treatment Outcomes: the INSTITUT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 769
- 试验地点
- 2
- 主要终点
- Percent of participants with an unfavorable outcome
研究概览
简要总结
Undernutrition is a leading global risk factor of tuberculosis (TB) and a prevalent comorbidity associated with TB. In Benin, the National TB Program systematically provides nutritional support to all persons with TB (PWTB), distributing prepared foods to hospitalized patients and food baskets during outpatient care. In Togo, the PWTB population is similar to that of Benin; however, Togo does not have a systematic program in place to provide nutritional support to these patients.
The investigators will perform a prospective cohort analysis using anonymized TB patient data from the National TB Programs of Benin and Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not. Participants in Togo who do not receive nutritional support will serve as a control. Unfavorable outcomes in both groups such as treatment failure, death, or relapse will be compared. The results from this study should help to shape TB programs in the future by incorporating nutritional support.
详细描述
The objectives of this prospective cohort analysis are:
- To estimate the impact of nutritional support on TB treatment outcomes
- To estimate the impact of nutritional support on the nutritional status of persons with TB (PWTB) at the end of treatment.
Pulmonary TB patients who meet eligibility criteria including being diagnosed with a smear-positive (>/=1+ AFB) and provide informed consent will be enrolled. A projected sample of 1050 participants will be enrolled and followed for approximately 12 months. 700 will be enrolled in Benin and 350 in Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not.
Sputum samples will be collected at baseline and month two to confirm diagnosis and resolution of disease. Chest X-rays will be taken at enrollment, if not available by the TB program, and repeated 6 months following the end of TB treatment to assess for post-TB chronic lung disease. At all visits, surveys will be administered to assess for response to treatment and functional and economic recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug susceptible, Xpert [polymerase chain reaction (PCR) test for TB] positive and/or sputum stain positive for AFB (≥1+)
- •Willing to attend follow-up visits and undergo study procedures
排除标准
- •Drug resistant TB
- •Has received 7 or more days of antimicrobial therapy
- •Based on study staff observation, the participant is too sick to enroll. Defined as a score of 4 on the World Health Organization (WHO) Performance assessment.
- •Pregnancy at the time of enrollment
- •Individuals who are unable to participate in the 6-minute walk test due to pre-existing mobility issues due to disability, trauma, neurological compromise, or cardiopulmonary issues
结局指标
主要结局
Percent of participants with an unfavorable outcome
时间窗: 12 months
An unfavorable outcome will be a composite of TB treatment failure, death, or relapse based on patient evaluation 6 months after treatment completion.
次要结局
- Number of participants with failure of sputum conversion(2 months)