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Rifampicin · 1 trial · 1 indication
The rifampicin concentrations in plasma are measured from blood samples that are obtained by intensive pharmacokinetic sampling at 6 sampling time points (h0, 1, 2, 4, 8, 12 post dose). CSF rifampicin concentration will be measured using CSF sample taken by means of lumbar puncture at hour 3-6 post dose at the same day of blood sampling.
| Arm | Type | Description |
|---|---|---|
| Rifampicin 450 mg (standard dose) | ACTIVE_COMPARATOR | Twenty patients will receive 1 tablet of 450 mg Rifampicin and 2 tablets of placebo once daily for 30 days. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT). After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin. Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) |
| Rifampicin 900 mg per oral | EXPERIMENTAL | Twenty patients will receive 2 tablets of 450 mg Rifampicin and 1 tablet of placebo once daily for 30 days. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT) After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin. Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) |
| Rifampicin 1350 mg per oral | EXPERIMENTAL | Twenty patients will receive 3 tablets of 450 mg Rifampicin and 0 tablet of placebo once daily for 30 days. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT) After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin. Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Patients receiving 450 mg rifampicin will receive additional 2 placebo tablets, while those who receive 900 mg rifampicin will receive 1 placebo tablet. Patients receiving 1350 mg rifampicin will not receive any placebo tablet. With this arrangement, every subject will receive 3 tablets of study drugs. |
| Rifampicin | DRUG | Patients in experimental arms will receive either 1 or 2 additional tablets of rifampicin. Placebo tablets will be added accordingly, so that every study subject will receive 3 tablets of rifampicin plus placebo as described in the Arms section. |
| Other TB drugs | DRUG | Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT) |
| Adjuvant dexamethasone | DRUG | Patients will receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) |
Inclusion Criteria: 1. Male or Female, aged 15 years or above. 2. Clinical suspicion of TBM and CSF/blood glucose ratio \< 0.5. 3. None or less than 3 days of anti-tuberculosis chemotherapy taken for the current infection. 4. Patient or representative (if the patient is incapacitated) is willing an...
Rifampicin is being studied for the treatment of Tuberculosis, Meningeal, a form of tuberculosis that affects the membranes surrounding the brain and spinal cord. It is a small molecule antibiotic being evaluated in a Phase 2 clinical trial to determine the appropriate dosing for this condition.
Rifampicin is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the drug for the treatment of Tuberculosis, Meningeal.
Rifampicin is in Phase 2 clinical development for the treatment of Tuberculosis, Meningeal. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under clinical investigation.
Rifampicin has been studied in one completed Phase 2 clinical trial with the identifier NCT02169882. The trial, titled 'High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study,' enrolled 60 participants in Indonesia and was designed to evaluate dosing for the treatment of Tuberculosis, Meningeal.
Yes, the Phase 2 clinical trial of Rifampicin for Tuberculosis, Meningeal was randomized and double-blind. The trial used an active-controlled design, meaning participants received either Rifampicin or an active comparator, and neither the participants nor the researchers knew which treatment was administered during the study.
The clinical trial for Rifampicin in Tuberculosis, Meningeal was biomarker-selected, indicating that participants were chosen based on specific biomarker criteria. However, the specific biomarker used for patient selection has not been disclosed in the available information.