High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

January 31, 2004

Study Completion Date

December 31, 2006

Conditions
Tuberculosis, Multidrug-Resistant
Interventions
DRUG

Isoniazid

"High-dose isoniazid (16-18 mg/kg/day) in addition to standardized regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)~Regular dose isoniazid (5 mg/kg/day) in addition to standard regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)"

DRUG

Placebo

Similar appearing and similarly packaged placebo tablets in addition to the standardized regimen that included the following: kanamycin (15 mg/kg/day), levofloxacin (7.5-15 mg/kg/day), protionamide (10-20 mg/kg/day), cycloserine (10-20 mg/kg/day) and p-aminosalicylic acid (150 mg/kg/day)

Sponsors
All Listed Sponsors
lead

GSVM Medical College

OTHER

NCT00513396 - High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis | Biotech Hunter | Biotech Hunter