- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00513396
High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis
A Randomized Control Trial Of High-Dose Isoniazid Adjuvant Therapy For Multidrug Resistant Tuberculosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consecutive patients reporting to the study center
- Sputum-positive for acid-fast bacilli
- HIV-uninfected
- MDR-TB defined as resistance to at least the following two drugs: Isoniazid and Rifampicin.
Exclusion Criteria:
- Unwilling to give consent
- Abnormal renal or hepatic profile
- History suggestive of isoniazid hypersensitivity
- Pregnancy
- Lactating mother
- Previous history of taking any of the following: kanamycin, prothionamide, levofloxacin, cycloserine and p-aminosalicylic acid
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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) |
Active Comparator: 2
|
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) |
Placebo Comparator: 3
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to sputum culture conversion
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Extent of radiological improvement
Time Frame: 1 year
|
1 year
|
Proportion with peripheral neuropathy
Time Frame: 1 year
|
1 year
|
Proportion with hepatotoxicity
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Tuberculosis, Multidrug-Resistant
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antimetabolites
- Hypolipidemic Agents
- Lipid Regulating Agents
- Anti-Bacterial Agents
- Antitubercular Agents
- Fatty Acid Synthesis Inhibitors
- Isoniazid
Other Study ID Numbers
- TB chest - 1/2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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