Health Condition 1: G01- Meningitis in bacterial diseases classified elsewhere
Conditions
Interventions
Intervention1: Arm - 1 (Intensified ATT with aspirin): Patients in this arm will receive a High dose of Rifampicin (Single dose - Once daily 25 mg/kg) and a weight based dose of Moxifloxacin (400mg on
Sponsors
Dr Leeberk RajaI
Eligibility
Inclusion criteria
Inclusion criteria: A patient will be eligible for entry to the trial if ALL of the following conditions are satisfied 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
Exclusion criteria: Patients will not be eligible for the trial if they meet ANY of the following criteria 1. Known current or 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 more than 450 ms in males and more than 460 ms in females measured in the 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality and disabilityTimepoint: The primary outcome will be mortality and disability as measured by modified Rankin scale at 12 months and 24 months. i.e., time from randomization to death during the follow-up period. Survivors will be censored at the date they were last known to be alive (i.e., date of last follow-up visit, loss to follow-up or withdrawal). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic parameters 2.Grade 3 and 4 adverse events 3. Quality of lifeTimepoint: 1.Plasma concentrations of HRhZ and Moxifloxacin will be estimated and the effects of baseline patient covariates on trial drug pharmacokinetics and associated clinical endpoints will be evaluated. 2.Comparison of the number of participants who develop Grade 3 or Grade 4 adverse events during treatment. 3.QoL at baseline and at 6 months, 12 months, and 24 months will be assessed using a WHO Short form -36 (SF-36) questionnaire. | — |
Countries
India
Contacts
Public ContactDr Leeberk RajaI
ICMR-National Institute for Research in Tuberculosis
Outcome results
None listed