Health Condition 1: J989- Respiratory disorder, unspecified
Conditions
Interventions
Intervention1: Test group: Econazole, 500mg once daily plus standard drugs (Moxifloxacin 600â??mg, oral Clofazimine 100â??mg, oral Ethambutol 800â??mg, oralPyrazinamide 1500â??mg, oral Isoniazid 300â?
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: - Adults with rifampicin-resistant and MDR-TB who have not been previously treated with second-line drugs. - Age more than or equal to 18 years - Willing to give written, informed consent - Willing to comply with protocol requirements
Exclusion criteria
Exclusion criteria: - Confirmed resistance to one or more drugs in the shorter MDR-TB regimen (except isoniazid resistance) - Suspected ineffectiveness of one or more drugs in the shorter MDR-TB regimen - Exposure to >1 second-line medicines in the shorter MDR-TB regimen for >1 month - Intolerance to >1 medicines in the shorter MDR-TB regimen or risk of toxicity (e.g. drug-drug interactions) - Pregnancy - Extrapulmonary disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum culture conversion (proportion of patients who become sputum culture negative) between two to four months, to determine if addition of econazole can lead to earlier response.Timepoint: Two months | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) Clinical cure at the end of treatment, as determined by the treating physicians, (ii) Bacteriological cure at the end of treatment, defined as three negative sputum cultures in the last month of treatment or if one culture was positive but cultures during the subsequent months were negative without additional chemotherapy (iii) RecurrenceTimepoint: 6 months | — |
Countries
India
Contacts
Public Contacti Samir Malhotra
PGIMER, Chandigarh
Outcome results
None listed