Intensified Short Course Regimen for TBM in Adults

Launched by INDIAN COUNCIL OF MEDICAL RESEARCH · Jun 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for tuberculous meningitis (TBM), a serious form of tuberculosis that affects the brain and can be life-threatening. The researchers want to see if a combination of short-course anti-TB drugs, including high doses of rifampicin and moxifloxacin, along with standard treatments and additional therapies, can improve outcomes for patients with TBM. Currently, there is a lot of uncertainty about how to treat this disease effectively, and the trial aims to provide clearer answers about the best treatment options.

To be eligible for the trial, participants must be adults over 18 years old, with or without HIV, and have a confirmed or likely diagnosis of TBM. They should also be willing to undergo testing, attend treatment sessions, and follow the study's procedures. However, individuals with certain medical conditions, drug resistance, or who are pregnant or breastfeeding will not be included in the study. If someone joins the trial, they can expect to receive either the new treatment regimen or standard care, and researchers will closely monitor their health throughout the process to ensure safety and effectiveness.

Gender

ALL

Eligibility 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:
• • Patients will not be eligible for the trial if they meet ANY of the following 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.