None listed
Conditions
Interventions
Intervention1: 4 month regimen
: 2HRZM / 2HRM
H- isoniazid - 10mg/kg
R - Rifampicin - 15 mg/kg
P- pyrinzamide - 35 mg/kg
M - moxifloxacin - 10mg/kg
Control Intervention1: 6 month regimen
: 2HRZE/4HRE
Sponsors
Indian Council of Medical Research (ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: Parent or guardian is willing and able to provide written informed consent for potential participant s study participation; in addition, when applicable potential participant is willing and able to provide assent for study participation. Diagnosed with microbiologically confirmed TB disease requiring 6 months standard of care, with or without signs and symptoms of TB. Microbiological confirmation includes MTB positive by NAAT (approved by central TB division for use in children) and/or culture and no resistance to quinolones by culture phenotypic DST and or LPA from; lymph node aspirate or FNAC sputum or alternative samples (gastric aspirate, nasopharyngeal aspirate and stool) Signs and symptoms of TB Eligible to be started on standard first-line drug-susceptible TB regimen in view of TB disease HIV negative Alanine aminotransferase within normal range Total bilirubin less than or equal to 2.5 times the upper limit of normal Willingness to be followed up for 2 years
Exclusion criteria
Exclusion criteria: Children diagnosed with Drug resistant TB (DR-TB): resistant to isoniazid, rifampicin, pyrazinamide, ethambutol, and/or fluoroquinolones. Clinically diagnosed TB disease (presumed TB) Extra pulmonary TB requiring more than 6 months regimen Hepatic or renal disease as evidenced by clinical or biochemical abnormalities Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs Prolonged QT syndrome Seizure disorder Pregnancy or lactation Any known contraindication to taking anti-TB drugs Evidence of significant medical condition which in the judgement of the Investigator would compromise the participant s health if he/she participates in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for efficacy is categorised as: 1. Favourable outcome; TB-free survival at 12 months post treatment completion 2. Unfavourable outcomes; a composite of failure, death, reinfection or recurrence 3. Not assessable; will include unknown outcomes at trial completion such as losses to follow-up after completing treatment and clinically well when last seen.Timepoint: 12 months post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with TB-free survival at 24 months post treatment completion among those treated with the 4month moxifloxacin containing daily regimen or 6 months standard regimen. The proportion of participants with adverse drug reactions Grade in those treated with the 4month moxifloxacin containing daily regimen or 6 months standard regimen. Proportion of participants with plasma moxifloxacin levels within normal or therapeutic range. To compare the adherence to treatment with 4month moxifloxacin containing daily regimen & 6 months standard regimen To describe the palatability & acceptability of 4 month regimen Timepoint: 24 months post treatment | — |
Countries
India
Contacts
Public ContactDr Aishwarya Venkataraman
ICMR-National Institute for Research in Tuberculosis,
Outcome results
None listed