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clarithromycin, rifabutin
Clarithromycin and rifabutin are macrolide and rifamycin antibiotics that inhibit bacterial protein synthesis and RNA-dependent RNA polymerase, respectively, used together to treat mycobacterial infections.
Clarithromycin and rifabutin are macrolide and rifamycin antibiotics that inhibit bacterial protein synthesis and RNA-dependent RNA polymerase, respectively, used together to treat mycobacterial infections. Used for Mycobacterium avium complex (MAC) infection prophylaxis and treatment in immunocompromised patients, Tuberculosis and atypical mycobacterial infections.
At a glance
| Generic name | clarithromycin, rifabutin |
|---|---|
| Also known as | Biaxin, mycobutin |
| Sponsor | The University of Texas Health Science Center at Tyler |
| Drug class | Macrolide antibiotic and rifamycin antibiotic combination |
| Target | Bacterial 50S ribosomal subunit (clarithromycin); bacterial RNA polymerase (rifabutin) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Clarithromycin is a macrolide antibiotic that binds to bacterial 50S ribosomal subunits to inhibit protein synthesis. Rifabutin is a rifamycin that inhibits bacterial RNA polymerase, blocking transcription. This combination is particularly effective against Mycobacterium avium complex (MAC) and other mycobacterial pathogens, with synergistic activity against resistant strains.
Approved indications
- Mycobacterium avium complex (MAC) infection prophylaxis and treatment in immunocompromised patients
- Tuberculosis and atypical mycobacterial infections
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal pain)
- Taste disturbance
- Headache
- Uveitis (rifabutin-associated)
- Discoloration of body fluids (rifabutin)
- Hepatotoxicity
Key clinical trials
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD) (PHASE2, PHASE3)
- Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (PHASE2, PHASE3)
- RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease (PHASE3)
- The Individualized M(X) Drug-resistant TB Treatment Strategy Study (PHASE4)
- Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease (PHASE2)
- Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs (PHASE1)
- Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS (PHASE3)
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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