Evaluating Point-of-care Ultrasound to Improve Tuberculosis Diagnosis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 576
- 试验地点
- 2
- 主要终点
- To describe the sonographic findings obtained by TB-focused POCUS methodology
研究概览
简要总结
Diagnosis of tuberculosis (TB) in children is particularly challenging in low and middle-income countries (LMIC), and a high number of children remain undiagnosed and untreated. A delay in diagnosis can lead to an increase in preventable morbidity and mortality. Point-of-care ultrasound (POCUS) is a bedside, non-invasive, inexpensive imaging tool, and TB-focused POCUS has been used and validated for adults with HIV. This study aims to describe the TB-focused POCUS findings for children with presumptive TB aged between 6 months and 15 years old, and to stratify the results per HIV, nutritional status and age. This is a Médecins Sans Frontières (MSF) multicentric study which takes place in Guinea Bissau and South Sudan.
详细描述
This study has as main objective to describe the findings obtained by POCUS methodology for pulmonary and extra-pulmonary tuberculosis in children per TB category. As secondary objectives: 1)To establish the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of POCUS positive (any of 8 pre-established sonographic signs) as a composite against a composite reference of the final diagnosis (confirmed TB, unconfirmed TB or unlikely TB). 2)To describe the sonographic signs according to HIV status (positive, negative) and to nutritional status (SAM or not SAM). 3)To determine the proportion of children with improvement / resolution of sonographic signs and the proportion without improvement of sonographic signs at 2 months of follow-up in children with and without TB. 4)To describe operational aspects of POCUS: compliance with POCUS examination; quality of POCUS; duration of POCUS; mean time to definitive diagnostic in POCUS positive results compared to POCUS negative results; proportion of children who started TB treatment on basis of POCUS positive results.
This is a multicentric study in 2 different sites: Malakal (South Sudan) and Bissau (Guinea Bissau). The methodology for the evaluation of POCUS for the diagnosis of TB in children will be longitudinal case series with diagnostic test evaluation.
Study participants: The research population are children with presumptive TB in Malakal (town and POC hospitals) or in Bissau (Simão Mendes National Hospital).
Case with diagnosis of tuberculosis:
- Confirmed TB: patients with Xpert MTB/RIF positive (or TB culture positive when available) in a respiratory sample (pulmonary TB) or in other sample, such as CSF, lymph node or other tissue/liquid (extra pulmonary TB); TB LAM positive in HIV-infected patients.
- Unconfirmed TB: no microbiological confirmation but clinical diagnosis of TB and started on anti TB treatment (as established in Appendix 4).
- Unlikely TB: good response to other treatments (antibiotic, nutritional support, etc.) and no suggestive symptoms after 1 week of admission.
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
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any child from 6 months of life to 15 years old
- •Presumptive TB according to diagnostic criteria
- •Informed consent provided by legal responsible or companion
排除标准
- •Patients who have received TB treatment for > 1 day in the last 3 months
- •Informed consent not provided by legal responsible or companion
结局指标
主要结局
To describe the sonographic findings obtained by TB-focused POCUS methodology
时间窗: At baseline
To describe the sonographic findings obtained by TB-focused POCUS methodology for pulmonary and extra-pulmonary tuberculosis in children per TB category
次要结局
- To describe the sonographic signs according to HIV status (positive, negative)(At baseline)
- To describe the sonographic signs according to nutritional status (severe acute malnutrition (SAM) or not SAM)(At baseline)
- To establish the sensitivity, specificity, positive predictive value and negative predictive value of POCUS positive as a composite against a composite reference of the final diagnosis(At baseline)
- To describe operational aspects of POCUS: mean time to diagnosis(At baseline)
- To determine the proportion of children with improvement / resolution of sonographic signs and the proportion without improvement of sonographic signs at 2 months of follow-up in children with and without TB(At 2 months)
- To describe operational aspects of POCUS: compliance(At baseline)
- To describe operational aspects of POCUS: duration of POCUS(At baseline)
研究者
Laura Moreto
Principal Investigator
Medecins Sans Frontieres, Spain