Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Intervention details are not applicable as we are comparing two diagnostic techniques.: NIL
Control Intervention1: Comparison: Comparison of yield of CBNAAT Positivity in sputum induced
Sponsors
Cipla Limited
Eligibility
Inclusion criteria
Inclusion criteria: Children with presumptive pulmonary tuberculosis or disseminated tuberculosis, defined as a child with any of the symptoms or signs suggestive of TB i.e.(NTEP guidelines 2023), Fever >2 weeks ,Significant weight loss (loss of >5% of highest weight recorded in the past 3 months) or not gaining weight, Cough >2weeks, Abnormalities of chest radiograph (parenchymal infiltrate, atelectasis, pleural effusion, or lymphadenopathy) ln contact of a TB case - Children with suspected immunodeficiency where PTB has to be ruled out , Children with chronic lung diseases (cystic fibrosis, bronchiectasis) where PTB should be ruled out
Exclusion criteria
Exclusion criteria: Children with a history of prior bronchospasm attributed to inhaled therapies, Children with a history of recent haemoptysis or pneumothorax ,Children with respiratory failure ,Patient with uncontrolled asthma or signs of upper airway obstruction. Unconscious children (GCS <8) or children with convulsions, Patients in whom consent could not be obtained, Children only with extrapulmonary TB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity, specificity, positive predictive value (PPV) Of CBNAAT Of induced sputum and GA respectively compared to the gold standard (MGIT)Timepoint: Only one time only at the time of diagnostic testing. | — |
Secondary
| Measure | Time frame |
|---|---|
| correlation between two methods of CBNAAT testing (sputum induction vs gastric aspirate/ lavage) b.To assess the feasibility of inducing an adequate amount of sputum c. To assess for adverse effects of sputum induction and gastric lavage d.To see how all three tests (sputum CBNAAT, GA/ GL CBNAAT and MGIT) correlate with clinically significant pulmonary tuberculosis Timepoint: Only one time only at the time of diagnostic testing. | — |
Countries
India
Contacts
Public ContactMonica Mahendru
AIIMS , Rishikesh
Outcome results
None listed