Clarithromycin
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Clarithromycin
- Clarithromycin: From Respiratory and Bacterial Infections to Polyclonal Hyperviscosity Syndrome
Clarithromycin: From Respiratory and Bacterial Infections to Polyclonal Hyperviscosity Syndrome
One-Sentence Summary
Clarithromycin is a macrolide antibiotic, originally used for bacterial infections such as pneumonia, sinusitis, otitis media and staphylococcal or streptococcal infections. The TxGNN model predicts it may be effective for polyclonal hyperviscosity syndrome, with a very high score. However, there are currently 0 clinical trials and 0 publications supporting this specific prediction, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Bacterial infections (otitis media, pneumonia, sinusitis, staphylococcal and streptococcal infections, Mycoplasma and Chlamydia pneumonia). The registration records contain no indication text, so this comes from the knowledge graph used by the model. |
| Predicted New Indication | Polyclonal hyperviscosity syndrome |
| TxGNN Prediction Score | 99.35% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Clarithromycin is a macrolide antibiotic whose efficacy in bacterial infections is well established. Mechanistically, any benefit in polyclonal hyperviscosity syndrome would be speculative and might relate to immunomodulation.
No trial, publication or plausible mechanism links clarithromycin to this condition. The high score alone is not enough to support a clinical hypothesis.
Better-supported alternative in the same prediction list: among the other predictions, monoclonal gammopathy (score 98.81%, evidence level L2) has the strongest support.
- A completed Phase II trial tested clarithromycin (Biaxin) plus DHEA in monoclonal gammopathy of undetermined significance.
- Many publications describe clarithromycin combined with lenalidomide, thalidomide or pomalidomide and dexamethasone in multiple myeloma and Waldenström's macroglobulinemia.
- Proposed mechanisms include autophagy inhibition and immunomodulation.
- Most of these data come from combination regimens in symptomatic myeloma, so clarithromycin's independent contribution is hard to separate.
Clinical Trial Evidence
Currently no related clinical trials registered for polyclonal hyperviscosity syndrome.
Literature Evidence
Currently no related literature available for polyclonal hyperviscosity syndrome.
Singapore Market Information
Clarithromycin has 20 valid single-ingredient registrations in Singapore and none are cancelled. Five main ones are listed below. The registration records contain no approved-indication text, so that column is omitted.
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| SIN07085P | KLACID TABLET 250 mg | Film-coated tablet |
| SIN09193P | KLACID FORTE TABLET 500 mg | Film-coated tablet |
| SIN09884P | KLACID MR TABLET 500 mg | Extended-release tablet |
| SIN09119P | KLACID IV FOR INJECTION 500 mg/vial | Powder for solution for injection |
| SIN09354P | KLACID GRANULES FOR ORAL SUSPENSION 125 mg/5 ml | Granules for suspension |
Oral tablets, extended-release tablets, oral suspension granules and an intravenous injection are all available.
Safety Considerations
- Contraindication-related conditions (from the knowledge graph, not label text):
- Cardiac: long QT syndrome, torsades de pointes, ventricular tachycardia (including catecholaminergic and infant forms)
- Liver and biliary: liver failure, liver disease, cholestasis (including benign recurrent and familial intrahepatic forms), gallbladder disease
- Metabolic: inherited porphyria and other porphyrias
- Neuromuscular: myasthenia gravis and neuromuscular junction disease
- Other: kidney disease, Clostridium difficile colitis, perinatal necrotizing enterocolitis, osteoporosis and bone fracture, infectious mononucleosis and chronic Epstein-Barr virus infection syndrome
- Drug interactions: 100 interactions are recorded and 20 are reviewed here.
- Major: abemaciclib, fentanyl, acalabrutinib
- Moderate: paclitaxel, tramadol, nifedipine, adenosine, afatinib, ethinylestradiol, hydrocortisone, formoterol, famotidine, acarbose, flunisolide, abametapir (topical), abiraterone, trastuzumab emtansine
- Minor: dolutegravir, zidovudine, loratadine
Please refer to the package insert for official warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The predicted indication of polyclonal hyperviscosity syndrome has a high model score, but no clinical trials, no literature and no identifiable mechanism. Clarithromycin is widely marketed in Singapore, but market availability does not support efficacy for this condition.
To proceed, the following is needed:
- Mechanism of action data and a plausible biological link to hyperviscosity syndrome
- Any preclinical or clinical evidence specific to this condition
- The package insert warnings and contraindications for Singapore-registered products
- A review of monoclonal gammopathy as a priority candidate, including the results of the completed Phase II trial NCT00006219. Its enrollment and outcomes are not available in the data compiled for this report.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.