Comparative evaluation of intensified short course regimen and standard regimen for adults TB meningitis : an open label randomized controlled trial (INSHORT trial) - INSHORT TRIA

Dr Leeberk RajaI0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

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•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

•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

发起方

Dr Leeberk RajaI