Health Condition 1: G01- Meningitis in bacterial diseases classified elsewhere
Conditions
Interventions
Intervention1: Intervention arm: HRZS: Patients will receive Isoniazide (H, 5 mg/Kg body weight, PO), rifampicin (R, 10 mg/Kg body weight, PO), pyrazinamide (Z, 25 mg/Kg body weight, PO) and Streptomy
Sponsors
AIIMS rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: All patients with fever and altered sensorium for 10 days or more of their illness will be included in the study. Definite and probable TBM diagnosed on the basis of clinical, CSF and radiological criteria will be included. The diagnosis of TBM will be based on clinical, CT or MRI scan and CSF criteria according to a uniform case definition (Marais et al, 2010). 1. Essential criteria: Features suggestive of meningitis (one or more of the following: headache, irritability, vomiting, fever, weight loss, neck stiffness, convulsions, focal neurological deficits, or altered consciousness) for more than five days. 2. Supportive criteria: (a) CSF cells of 10 â??500/μL, with predominant lymphocytes ( >50%), protein 1 g/L and sterile bacterial and fungal culture. (b) Cranial CT or MRI imaging showing evidence of exudates, infarction, hydrocephalus or tuberculoma in isolation or in combinations. (c) Evidence of extra CNS tuberculosis (chest radiograph suggestive of active tuberculosis or CT, MRI or ultra-sonographic evidence of tuberculosis outside the CNS or Acid Fast Bacilli (AFB) identified or Mycobacterium tuberculosis cultured from another source such as sputum, lymph node, gastric washing, urine). (d) Exclusion of alternative diagnoses. Presence of essential and 3 of 4 supportive criteria will be considered highly probable and 2 supportive criteria as probable TBM. Presence of AFB in CSF smear or culture, positive PCR for M. tuberculosis in CSF will be considered definitive evidence of TBM
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women will be excluded. The patients with serological evidence of Hepatitis A, B, C, E, ultra-sonographic (USG) evidence of chronic liver disease (CLD) or gall bladder disease, human immunodeficiency virus (HIV) infection, long term alcoholism (defined as consumption of 148 g of alcohol per day for at least 1 year), concomitant consumption of other potentially hepatotoxic drugs (eg, methotrexate, phenytoin, valproate, and fluconazole) and failure to give written informed consent. Patients with, chronic renal failure, hepatic failure, heart failure, carcinomatous meningitis and contra-indications to ATT, steroids or aspirin will also be excluded. 2. Patients with pre-existing visual disturbances, hearing loss (any grade) or vestibular dysfunction will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was death by 6 months after randomization. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. number of patients developing Side effects due to treatment. 2. Disability (defined by m RS) at discharge, 3 and 6 months. 3. Time to the first new neurologic event or death, and serious adverse events.Timepoint: 3 and 6 months | — |
Countries
India
Contacts
Public ContactDr Mritunjai Kumar
AIIMS Rishikesh
Outcome results
None listed