Health Condition 1: J00-J99- Diseases of the respiratory system Health Condition 2: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
None listed
Sponsors
Maulana Azad Medical College
Delhi State TB Cell
Eligibility
Inclusion criteria
Inclusion criteria: 1)Newly diagnosed pulmonary tuberculosis patients taking daily antitubercular drugs according to NTEP guidelines(2019) 2)Patiients diagnosed with type 2 diabetes mellitus( on diet control or oral antidiabetic drugs or fasting BG >126mg/dl or postprandial BG >200 mg/dl or random BG >200mg/dl or HbA1c >6.5% 3) Sensitive to rifampicin detectced by cartridge based nucleic acid amplification test(CBNAAT)
Exclusion criteria
Exclusion criteria: Patients with 1)Abnormal liver function tests(AST or ALT or both >50 IU) 2) Abnormal renal function tests( Creatinine >1.5mg/dl and urea >40 mg/dl) 3) Pregnant and nursing mothers 4) On concomitant Anti retroviral treatment 5) On immunosuppressive medication 6) On corticosteroid therapy 7) Body weight less than 30kg 8)sick or moribund patients 9)Patients developing severe adverse drug reactions during treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Drug levels of isoniazid, rifampin, pyrazinamide and ethambutol over 12 hours after drug administration 2) Pharmacokinetics parameters-peak serum concentration(Cmax), Time to reach peak serum plasma concentration( Tmax), Absorption rate constant(kab), volume of distribution(vd), area under plasma concentration time curve(AUC 0-24), area under plasma concentration time curve infinity, elimination half life, elimination rate Constant, Clearance Timepoint: 0,1,2,3,4,8,12 hours after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Sputum conversion(ZN stain and MGIT culture)Timepoint: at the end of 2months and 6months of antitubercular therapy;Correlation between peak drug concentration of antitubercular drugs and sputum conversionTimepoint: at the end of 2 months and 6months of antitubercular therapy started;Association between sputum conversion and status of diabetes mellitusTimepoint: At the end of 2months and 6months of antitubercular therapy;Association and resolution of clinical symptoms(fever, increase appetite, weight gain) with coexisting diabetes mellitus, antitubercular drug levelsTimepoint: after 2months and 6months of antitubercular therapy initiated | — |
Countries
India
Contacts
Public ContactDr Sourav Mondal
Maulana Azad Medical college and Lok Nayak Hospital
Outcome results
None listed