Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
372 participants
INTERVENTIONAL
2024-03-31
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm- 1( Intervention arm with aspirin)
Intensified with high dose rifampicin, moxifloxacin, aspirin and steroids in the initial two months.
High dose rifampicin (25mg/kg)
Given for 2 months
Moxifloxacin 400mg
Given for 2 months
Aspirin 150 mg
Given for 2 months
Isoniazid
Given for 6 months
Pyrazinamide
Given for 6 months
Steroid
Tapering dose of dexamethasone or prednisolone upto 8 weeks
Rifampicin
Standard dose for 4 months after the initial treatment with high dose
Arm -2 (Intervention arm without aspirin)
Intensified with high dose rifampicin, moxifloxacin and steroids in the initial two months.
High dose rifampicin (25mg/kg)
Given for 2 months
Moxifloxacin 400mg
Given for 2 months
Isoniazid
Given for 6 months
Pyrazinamide
Given for 6 months
Steroid
Tapering dose of dexamethasone or prednisolone upto 8 weeks
Rifampicin
Standard dose for 4 months after the initial treatment with high dose
Arm -3 (Control)
Regimen as per the current National Tuberculosis Elimination Program in India.
HRZE
2 months
HRE
7-10 months as per TB program guidelines
Interventions
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High dose rifampicin (25mg/kg)
Given for 2 months
Moxifloxacin 400mg
Given for 2 months
Aspirin 150 mg
Given for 2 months
Isoniazid
Given for 6 months
Pyrazinamide
Given for 6 months
Steroid
Tapering dose of dexamethasone or prednisolone upto 8 weeks
Rifampicin
Standard dose for 4 months after the initial treatment with high dose
HRZE
2 months
HRE
7-10 months as per TB program guidelines
Eligibility Criteria
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Inclusion Criteria
1. Adults (\> 18 years) with or without HIV infection
2. Possible, probable or definite TBM according to Lancet consensus diagnostic criteria
3. Willing to give written informed consent
4. Is willing to have an HIV test.
5. Residing within 100 km of the study sites
6. Express willingness to attend the treatment centre for supervised treatment
7. Express willingness to adhere to the trial procedures and follow-up schedule.
8. Agrees to use effective barrier contraception during the period of the treatment in case of female participants
Exclusion Criteria
1. Known current/previous drug resistance to ATT (Rifampicin, INH, FQ)\*\*
2. Concurrent or known diagnosis any other meningitis such as bacterial, viral, and fungal.
3. Currently having an uncontrolled cardiac arrhythmia or ECG abnormalities which are contradiction for the administration of moxifloxacin including prolonged QTc. QTc value define as \>450 ms in males and \>460 ms in females measured in lead II or V5 on a standard 12-lead ECG.
4. Has clinical icterus or hepatic impairment characterized by serum bilirubin level above the normal laboratory reference range with abnormal liver enzymes, or isolated alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) levels above 5 times the upper limit of the normal laboratory reference range
5. Previous history of anti-TB treatment, If any, should not exceed one month in the past and not more than 7 days in the preceding one month.
6. pregnant or lactating women
7. rapid clinical deterioration or very sick and moribund during the screening process, renal failure, liver disease or any condition (social or medical) that in the opinion of the investigator would make trial participation unreliable or unsafe.
8. Has a known allergy to any of the drugs proposed to be used in the trial regimen
* All participants with Rifampicin resistance will be excluded at baseline from the study. Participants with H, FQ and Z resistance identified from MGIT results done at baseline will be referred back to NTEP for appropriate management and their numbers will be compensated.
18 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences, Jodhpur
OTHER_GOV
Christian Medical College, Vellore, India
OTHER
Jawaharlal Institute of Postgraduate Medical Education & Research
OTHER_GOV
North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences
OTHER_GOV
Madras Medical College
OTHER_GOV
Rural Development Trust Hospital
OTHER
Indian Council of Medical Research
OTHER_GOV
Responsible Party
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Leeberk Raja Inbaraj
Scientist-E (Medical)
Locations
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ICMR- National Institute for Research in Tuberculosis
Chennai, Tamil Nadu, India
Countries
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Central Contacts
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Facility Contacts
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References
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Inbaraj LR, Manesh A, Ponnuraja C, Bhaskar A, Srinivasalu VA, Daniel BD. Comparative evaluation of intensified short course regimen and standard regimen for adults TB meningitis: a protocol for an open label, multi-center, parallel arms, randomized controlled superiority trial (INSHORT trial). Trials. 2024 May 2;25(1):294. doi: 10.1186/s13063-024-08133-6.
Other Identifiers
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NIRT-IEC No:2023 003
Identifier Type: -
Identifier Source: org_study_id
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