Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Dr Kalpana Sriraman
Dr Ambreen Shaikh
Dr Nerges Mistry
Eligibility
Inclusion criteria
Inclusion criteria: Child with signs and symptom(s) suggestive of TB OR Confirmation of pulmonary TB disease at the time of screening with microbiological confirmation of TB disease
Exclusion criteria
Exclusion criteria: Children will be excluded from the study if: - 1. They are too sick to provide a sample for SMaRT-PCR as deemed by the clinician 2. They have been given three or more daily doses of TB treatment before the first study sample is taken.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity and positive and negative predictive values of SMaRT-PCRTimepoint: 24 months and 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance of resistance determination by SMaRT-PCR with Whole Genome SequencingTimepoint: 48 months;Prevalence of confirmed paediatric TB among children with presumptive TBTimepoint: 48 months;Understanding operational challenges associated with implementation of SMaRT-PCR diagnostic workflow for paediatric pulmonary TB diagnosis in diverse geographical and resource settingsTimepoint: 48 months | — |
Countries
India
Contacts
Public ContactDr Kalpana Sriraman
The Foundation for Medical Research
Outcome results
None listed