|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | GSVM Medical College |
|---|---|
| Information provided by: | GSVM Medical College |
| ClinicalTrials.gov Identifier: | NCT00513396 |
Purpose
The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB) in resource-limited countries is being increasingly recognized. This single center, double blind, randomized controlled trial was designed to compare the time required for sputum culture conversion and extent of radiological improvement in cases of MDR pulmonary tuberculosis when isoniazid was included (both at a regular dose and at a high dose) as an adjuvant to the standardized second line of treatment. The study was designed to test the hypothesis that inclusion of high-dose isoniazid will enhance the effectiveness of the second line of treatment in cases of MDR-TB without significantly increasing the toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis, Multidrug-Resistant |
Drug: Isoniazid Drug: Placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Control Trial Of High-Dose Isoniazid Adjuvant Therapy For Multidrug Resistant Tuberculosis |
| Enrollment: | 134 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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) |
| 2: Active Comparator |
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) |
| 3: Placebo Comparator |
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)
|
Tuberculosis was declared a global emergency by the World Health Organization (WHO) in 1993. The global problem of tuberculosis is further complicated by a substantial increase in drug resistant tuberculosis. Available data suggest that drug resistant TB especially multi drug resistant may represent a public health threat in areas with a high prevalence of tuberculosis, suboptimal TB control programmes and/ or HIV. The cure rate of these cases has been reported to be lower than for non-drug resistant TB with a failure rate of 44%. New therapies for MDR-TB have not been introduced since the fluoroquinolones in the 1970s. Strains of Mycobacterium Tuberculosis (M. tub.) in H resistant cases often contain mixture of susceptible & resistant organisms. Use of high dose H (16- 20 mg/kg) can eliminate susceptible & those with low level resistance4. This Study was done to evaluate the role of isoniazid (INH) at high & normal dosages as an adjuvant therapy in treatment of patients with persistent culture positive pulmonary tuberculosis despite 6 months of continuous first line antitubercular treatment and on culture at least resistant to isoniazid and rifampicin.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Chair: | Subodh Katiyar, MD | GSVM Medical College, Kanpur, India |
| Principal Investigator: | Shivesh Prakash, MBBS | GSVM Medical College, Kanpur, India |
| Principal Investigator: | Shailesh Bihari, MD | GSVM Medical College, Kanpur, India |
| Principal Investigator: | Hemant Kulkarni, MD | Lata Medical Research Foundation, Nagpur, India |
| Principal Investigator: | Manju Mamtani, MD | Lata Medical Research Foundation, Nagpur, India |
More Information
| Study ID Numbers: | TB chest - 1/2005 |
| Study First Received: | August 6, 2007 |
| Last Updated: | August 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00513396 History of Changes |
| Health Authority: | India: Institutional Review Board |
|
Randomized control trial multidrug resistant tuberculosis isoniazid standardized regimen adjuvant therapy |
|
Antimetabolites Bacterial Infections Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Tuberculosis, Multidrug-Resistant Immunologic Factors Antilipemic Agents Physiological Effects of Drugs Adjuvants, Immunologic Actinomycetales Infections |
Pharmacologic Actions Anti-Bacterial Agents Gram-Positive Bacterial Infections Therapeutic Uses Mycobacterium Infections Tuberculosis Antitubercular Agents Fatty Acid Synthesis Inhibitors Isoniazid |
