CTRI/2020/01/022899尚未招募未知
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
The Foundation for Innovative New Diagnostics0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Participants are eligible to be included in the study only if all of the following inclusion criteria apply:
- •14 years of age or younger
- •Written parent/guardian consent
- •Child assent based on age and national ethical guidelines of the countryâ??s regulations
- •Willingness to have a study follow-up visit approximately at 2-3 months after enrolment
- •(e.g. not planning to relocate)
- •One or more of:
- •Microbiological confirmation of active TB disease (by smear, Xpert or culture) e.g. children
- •referred from non-study health facilities
- •Clinical suspicion of active pulmonary with or without extra-pulmonary TB disease
- •(one or more of the following, based on investigatorâ??s judgement):
- •Pulmonary TB, Extra-pulmonary TB , Chest X-ray suggestive of TB
- •Weight loss or failure to thrive within 3 months not solely due to inadequate feeding, or another
- •non-TB cause
- •Any cough with loss of weight, Cough alone >=14 days, Persistent ( >1 week) and unexplained fever2
- •Enlarged lymph nodes for >2 weeks, not painful to palpation ,Gibbus of recent onset, Non-painful
- •enlarged joint, Pleural effusion, Pericardial effusion, Headache
- •CSF examination findings in line with TB meningitis OR signs and symptoms in line with TB meningitis if lumbar puncture is contraindicated3 AND/OR >=2 of4: lethargy, convulsion, meningism (neck stiffness), headache
- •Any of: cavity, hilar/mediastinal lymph node enlargement, miliary pattern, unilateral hyperinflation due to ball valve effect, expansile pneumonia and/or pleural effusion
- •Fever >38°C reported by a parent/guardian or objectively recorded at least once by study staff per instructions in the Study Manual
- •Palsy of oculomotor nerves of recent onset, focal neurological symptoms indicating elevated intracranial pressure or CNS lesions of recent onset For malaria-endemic areas in addition child has negative malaria rapid diagnostic test.
排除标准
- •Participants are excluded from the study if any of the following exclusion criteria apply:
- •-Anti-TB treatment for >72 hours or any antibiotic with anti-mycobacterial activity within 60 days prior to enrolment (e.g. including children receiving or having received isoniazid preventive therapy).
- •-Unstable or severe clinical status, as determined by study medical staff, which would endanger the child to participate in any of the required study procedures, including specimen sampling (e.g. hypovolemic shock or clinically relevant anaemia, tachypnoea, tachycardia).
- •-Body weight less than 2 kg.
- •Children who consent (parent consent or assent) to participate in the study but are not able to provide sufficient volume and/or number of stool samples per protocol will be classified as early withdrawals and a new study subject enrolled.
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