Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513396
Status:
COMPLETED
Last Update Posted:
2007-08-08
First Post:
2007-08-06
Brief Title:
High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis
Sponsor:
GSVM Medical College
Organization:
GSVM Medical College
Study Overview
Official Title:
A Randomized Control Trial Of High-Dose Isoniazid Adjuvant Therapy For Multidrug Resistant Tuberculosis
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None