Health Condition 1: J22- Unspecified acute lower respiratory infection
Conditions
Interventions
None listed
Sponsors
The Foundation for Innovative New Diagnostics
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the diagnostic accuracy of a single Ultra/SPK for TB detection using microbiological confirmation on respiratory specimens as reference standardTimepoint: Day 1 Day 2 Month 2-3 Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the diagnostic accuracy of a single Ultra/SPK for TB detection using the Revised classification for diagnostic evaluation studies diagnostic accuracy of a single Ultra/SPK for RIF resistance detection with phenotypic MGIT DST on respiratory specimens as reference standard. Timepoint: Day 1 Day 2 Month 2-3 Month 6 | — |
Countries
India
Contacts
Public ContactAshish Bavdekar
KEM Hospital Research Centre
Outcome results
None listed