Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917340
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-06-08
Brief Title:
Intensified Short Course Regimen for TBM in Adults
Sponsor:
Indian Council of Medical Research
Organization:
Indian Council of Medical Research
Study Overview
Official Title:
Comparative Evaluation of Intensified Short Course Regimen and Standard Regimen for Adults TB Meningitis an Open-label Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
INSHORT
Brief Summary:
Tuberculous meningitis TBM is the most lethal form of extra pulmonary tuberculosis This devastating disease kills almost a third of its sufferers and disables a significant proportion of the survivors TBM poses one of the most difficult diagnostic and therapeutic challenges in modern clinical practice High-quality robust clinical trials have made a considerable contribution to the treatment of pulmonary tuberculosis in the last four decades However evidence from such clinical trials is lacking in TBM and the treatment remains uncertain There is a significant variation in the choice dose and duration of drugs between countries institutions and clinicians Investigators propose a multi-centric open-label clinical trial to assess the efficacy of short-course anti-TB drugs with high dose rifampicin and moxifloxacin along with conventional anti-TB drugs and adjuvant therapy with aspirin and corticosteroids Controls will receive standard treatment as per national guidelines for TBM The investigators also aim to assess the safety and tolerability of high-dose Rifampicin and Moxifloxacin and the Pharmacodynamics and Pharmacokinetics parameters of ATT Rifampicin INH Moxifloxacin and Pyrazinamide in CSF between the two groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None