None listed
Conditions
Interventions
Intervention1: Prevent TB among household contacts of fluoroquinolone resistant drug resistant TB patients in Mumbai: Total 15 months out of which 9 months for participant recruitment and 6 months of
Sponsors
BMC(NTEP)
SHARE INDIA
Eligibility
Inclusion criteria
Inclusion criteria: Age Adults greater than 18 years and children aged greater than 5 years HHCs. 2. All HHCs of an index bacteriologically phenotype or genotype confirmed DR TB patients resistant to FQ. 3. Willing for study procedures. 4. Willing to provide written informed consent, adults greater than 18years and assent for children aged greater than 6years.
Exclusion criteria
Exclusion criteria: 1. Critically ill 2. Unable to take oral medications 3. Body weight lesser than 16 Kg 4. Current smear or GeneXpert or LPA or culture confirmed or clinically diagnosed Pulmonary or Extra pulmonary TB 5. Currently receiving anti TB treatment 6. Past AntiTB treatment at any time for more than 1 month during 1 year prior to enrolment 7. All HHCs of an index bacteriologically phenotype or genotype confirmed FQ resistant DR TB patients with Mtb resistant to Delamanid by tNGS or pDST. 8. Participants with abnormal chest X ray that cannot be excluded from having TB disease 9. Alcohol or substance use or dependence 10. Significant cardiac arrhythmia requiring medication 11. Study participants who have QTcF interval on ECG more than 450 m sec at screening. 12. Females who have a positive pregnancy test at screening or already known to be pregnant, breast feeding, or planning to conceive a child during the study or within 6 months of cessation of treatment. Males planning to conceive a child during the study or within 6 months of cessation of treatment. 13. Study participants with the following laboratory values as defined by the enhanced Division of Microbiology and Infectious Disease DMID adult toxicity table November 2007 at screening will be excluded labs may be repeated In the absence of clinical symptoms if a. Aspartate aminotransferase AST greater than or equal to 5.0 ULN b. Alanine aminotransferase ALT than or equal5.0 ULN. c. Total bilirubin than or equal 1.2 ULN. - In the presence of Clinical symptoms if a. Aspartate aminotransferase AST than or equal 3.0 ULN b. Alanine aminotransferase ALT than or equal 3.0 ULN. c. Total bilirubin than or equal ULN. 14. Malignancy 15. Any condition in the investigators opinion where participation in the study would compromise the well being of study participant or prevent, limit or confound protocol specified assessments 16. Evidence or History of known drug allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of TB among the participantsTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants having TBI 12months 2. Proportion of participants who were initiated on TPT 12 months 3. Proportion of participants who developed ADRs due to DLM preventive therapy 12months 4. Proportion of participants who completed the DLM TPT 15months 5. Proportion of participants who developed TB diseases in follow up 18 months & 24 months Timepoint: 12months 15months 18months 24months | — |
Countries
India
Contacts
Public ContactDR VARSHA PURI
Brihanmumbai Municipal Corporation (BMC)
Outcome results
None listed