Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: Amikacin+Levofloxacin+ Ethambutol: 500mg+ 500mg+800mg
IV+ Oral +Oral
OD+OD+OD
Intervention2: Nil: Nil
Control Intervention1: Isoniazid+Rifampicin+Pyrazinamide+Ethambutol: 75mg+150mg+400
Sponsors
SRM College of Pharmacy
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed pulmonary tuberculosis confirmed by sputum AFB (or equivalent microbiological test) and consistent chest imaging (CXR or CT). Baseline liver and renal function tests available prior to or at treatment initiation (ALT, AST, total bilirubin, ALP, serum creatinine, eGFR). Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Children less than 18 years and pregnant or breastfeeding women, Known chronic liver disease or prior documented drug-induced liver injury, Known chronic kidney disease with eGFR less than 50 mL/min/1.73 m . Baseline QTc prolongation or taking other QT-prolonging drugs. Known allergy or contraindication to study drugs. Current use of other significant hepatotoxic drugs or substance use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy (in terms of sputum conversion rate and radiological improvement) between patients continuing FDC therapy and those receiving a modified anti-tubercular regimen. Timepoint: Sputum conversion Test- Baseline, week 8 and Chest X-Ray- Baseline, week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare the incidence of hepatotoxicity between the FDC and modified regimen groups. To assess treatment compliance and tolerability in both groups during the two-month follow-up period. To identify and analyze adverse drug reactions (ADRs) associated with each regimen. Timepoint: Incidence of hepatotoxicity- baseline, week 8. | — |
Countries
India
Contacts
Public ContactBalaji R
SRM Institute of Science and Technology, Kattankulathur
Outcome results
None listed