Multicentre Study to Evaluate the Diagnostic Accuracy of a Stool Processing Kit Combined With Xpert MTB/RIF Ultra for Paediatric TB Diagnosis Using Microbiological Confirmation on Respiratory Samples as the Reference Standard
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Sensitivity and specificity of a single Ultra/SPK using microbiological confirmation on respiratory specimens as reference standard
研究概览
简要总结
This is a prospective, multicenter cohort study in which the accuracy and the diagnostic yield of the Stool Processing Kit (SPK) in combination with Xpert Ultra MTB/RIF (Ultra) on stool samples will be assessed using a microbiological reference standard and a composite reference standard among children with signs and symptoms of pulmonary tuberculosis.
详细描述
FIND and partners have developed a simple Stool Processing Kit (SPK) that will enable processing of large numbers of stool samples, removal of PCR (polymerase chain reaction) inhibitors which can be used at level 1 health facilities in low and middle income countries.
The SPK is not a diagnostic kit as such but rather a sample processing method. This study aims to determine the sensitivity and specificity of Xpert Ultra MTB/RIF (Ultra) combined with SPK for TB detection using microbiological confirmation on respiratory specimens (defined as sputum, naso-pharyngeal aspirate, and/or gastric aspirate) as the reference standard. The investigators will further evaluate operational characteristics, including implementation considerations that will be needed for the potential rollout of the SPK.
Additionally, a comparison of the performance of the SPK with up to two other centrifuge-free stool processing methods will be done on the same stool samples. The first is a method developed by researchers at the KNCV Tuberculosis Foundation (Single One Step Stool) which does not require any additional reagents other than the Ultra Sample Reagent. The second is a method developed by the Pediatric Asian African Network for Tuberculosis and HIV Research (PANTHER) group, the Optimized Sucrose Flotation method. Another diagnostic candidate, the urine Fujifilm SILVAMP TB LAM (FujiLAM) test will be assessed during the study.
Therefore, if the sensitivity of any of these tests is shown to be promising this may support further research and provide other alternatives to respiratory samples.
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
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of 14 years of age or younger
- •Written parent/guardian consent and child assent based on age and national ethical guidelines
- •Willingness to have a study follow-up visit
- •Clinical suspicion of active pulmonary TB* OR microbiological confirmation of active TB disease referred from non-study health facilities
- •Chest X-ray suggestive of TB, or weight loss or failure to thrive within 3 months not solely due to inadequate feeding, or another non-TB cause, or any cough with loss of weight, or cough alone >=14 days, or persistent (>1 week) and unexplained fever
排除标准
- •Anti-TB treatment for >5 days or any antibiotic with anti-mycobacteria activity within 60 days prior to enrollment including children on Isoniazid Preventive Therapy
- •(confirmed) extra-pulmonary TB only
结局指标
主要结局
Sensitivity and specificity of a single Ultra/SPK using microbiological confirmation on respiratory specimens as reference standard
时间窗: 2 months
Point estimates of sensitivity and specificity with 95% confidence intervals, using microbiological confirmation including two cultures and two Xpert MTB/RIF Ultra in respiratory samples
次要结局
- Diagnostic accuracy of a single Ultra/SPK for Rifampin resistance detection(2 months)
- Diagnostic accuracy of a single Ultra/SPK for TB detection per subgroup(2 months)
- Diagnostic accuracy of additional interventions: Simple One Step (SOS), Optimized Sucrose Flotation (OSF) and Fujifilm SILVAMP TB LAM(2 months)
- Feasibility and user appraisal of the different stool processing methods(6 months)
- Diagnostic accuracy of a single Ultra/SPK using the National Institutes of Health (NIH) consensus definition as reference standard(2 months)
- Additional yield (increase in sensitivity) of a 2nd Ultra/SPK(2 months)