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MDR-TB Treatment Regimen(WHO)
A standardized combination regimen of multiple anti-tuberculous drugs designed to overcome drug resistance in multidrug-resistant tuberculosis (MDR-TB) by targeting Mycobacterium tuberculosis through multiple mechanisms simultaneously.
A standardized combination regimen of multiple anti-tuberculous drugs designed to overcome drug resistance in multidrug-resistant tuberculosis (MDR-TB) by targeting Mycobacterium tuberculosis through multiple mechanisms simultaneously. Used for Multidrug-resistant tuberculosis (MDR-TB), Tuberculosis resistant to isoniazid and rifampicin.
At a glance
| Generic name | MDR-TB Treatment Regimen(WHO) |
|---|---|
| Also known as | WHO Regimen |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Drug class | Antituberculous combination therapy |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
MDR-TB treatment regimens typically combine fluoroquinolones, injectable agents (aminoglycosides or polypeptides), and oral second-line drugs that inhibit bacterial cell wall synthesis, protein synthesis, and DNA replication. The WHO-recommended regimen uses a longer intensive phase followed by a continuation phase to sterilize lesions and prevent relapse while managing resistance patterns. The multi-drug approach reduces the likelihood of selecting for additional resistance mutations.
Approved indications
- Multidrug-resistant tuberculosis (MDR-TB)
- Tuberculosis resistant to isoniazid and rifampicin
Common side effects
- Ototoxicity (hearing loss)
- Nephrotoxicity
- Peripheral neuropathy
- Hepatotoxicity
- Gastrointestinal disturbances
- Arthralgia
- Hypothyroidism
Key clinical trials
- Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB (PHASE2)
- An Adaptive Randomized Controlled Trial (NA)
- Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB (PHASE2)
- Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB) (PHASE3)
- Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q) (PHASE3)
- Evaluating Newly Approved Drugs for Multidrug-resistant TB (PHASE3)
- Treatment Shortening of MDR-TB Using Existing and New Drugs (PHASE2)
- A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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