Health Condition 1: null- Minimal Tuberculosis in Children.
Conditions
Interventions
Intervention1: ATT given for 4 months duration: Intensive phase 2 months of HRZE (Isoniazid H,Rifampicin R, Pyrazinamide Z, Ethambutol E) daily &
Continuation phase 2 months of HRE (Isoniazid H, Rif
Sponsors
University College London
B J Medical College and Sassoon General hospitals Pune
Government Stanley Medical College Hospital Institute of Social Pediatrics Chennai
Madras Medical College Institute of Child Health and Hospital for Children Chennai
National Institute for Research in Tuberculosis Chennai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 0-16 years 2. Weight >= 3kg. This has been expanded to include children weighing between 3 and 4kg; a detailed PK study of individual drugs in infants is ongoing and data using the new FDC from this study will ensure that use of this new formulation is also studied in these smallest infants. 3. Clinician has decided to treat with standard first-line regimen (intensive phase of 4 drugs or 3 drugs as per local practice) 4. Symptomatic but non-severe TB including: a. extrathoracic lymph node TB; intra-thoracic uncomplicated (hilar) lymph node TB b. minimal or no parenchymal abnormality on CXR c. smear gastric aspirate/other respiratory sample (minimum 2 samples) negative Note: GeneXpert may be positive or negative; culture of respiratory sample may be positive or negative; lymph node aspirate may be smear/culture/GeneXpert positive or negative) 5. Not previously treated for TB or successfully treated for TB > 2 years since last completed treatment 6. Known HIV status; HIV-infected or HIV-uninfected 7. Willing and likely to adhere to 72 weeks follow up 8. Informed written consent from the parent/legal caregiver(s) and assent in children, as per local Ethics Committee guidance 9. Home address accessible for visiting and intending to remain within the recruitment area for follow up 10. Since participants will all be under legal age of independent consent, a parent or legal guardian must be willing and able to provide informed consent. If the subject is of appropriate age, she/he will also be asked to give assent if developmentally appropriate and clinically possible. 11. Participant can comply with the protocol requirements in the opinion of the site investigator.
Exclusion criteria
Exclusion criteria: 1. Smear-positive respiratory sample TB (note: smear-positive peripheral lymph node sample is allowed) 2. Premature ( 3. Miliary TB, spinal TB, TB meningitis, osteo articular TB, abdominal TB, congenital TB 4. Pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment e.g. liver or kidney disease, peripheral neuropathy, cavitation 5. Any known contraindication to taking anti-TB drugs 6. Known contact with drug resistant adult source case (including mono-resistant TB) 7. Known drug resistance in the child 8. Severely sick 9. Pregnancy 10. A clinically significant active medical condition or the presence of any concomitant severe illness or rapidly deteriorating health condition (outside of TB), which, in the opinion of the site investigator, would prevent appropriate participation in the trial, or that would make implementation of the protocol or interpretation of the study results difficult, or otherwise make the subject a poor candidate for a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TB disease free survival 72 weeks post randomisation will be determined by the ERC and categorised as: 1. Favourable 2.Unfavourable (including death, reinfection or relapse) or 3. Not assessable (e.g. lost to follow-up) Timepoint: 72 weeks post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality 2. Adverse drug reactions within 30 days of completing treatment 3. Relapse/re-infection-free survival including only cases adjudicated to be TB by the independent ERC 4. Suppressed HIV viral load at 24 and 48 weeks in HIV-infected children 5. Adherence and acceptability 6. Bacterial infections (requiring hospitalisation) Timepoint: 72 weeks post randomisation | — |
Countries
India, South Africa, Uganda, Zambia
Contacts
Public ContactDr Vidya Mave
National Institute for Research in Tuberculosis
Outcome results
None listed