Chloramphenicol
| Evidence Level: L5 | Predicted Indications: 8 |
Table of Contents
Chloramphenicol: Diffuse scleroderma
One-Sentence Summary
Chloramphenicol is a broad-spectrum antibacterial that is marketed in India in oral, ophthalmic and other forms. The TxGNN model predicts it may be relevant to diffuse scleroderma, with a score of 0.9965. There are no clinical trials and only 4 basic-research publications on this disease, none of which tests chloramphenicol, so this is a model prediction without supporting clinical evidence.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Diffuse scleroderma |
| TxGNN Prediction Score | 0.9965 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Chloramphenicol is generally known as an antibacterial that acts on the prokaryotic 50S ribosomal subunit.
The retrieved papers for diffuse scleroderma concern transcriptional regulation of the alpha1(I) procollagen gene, Smad3/Sp1/p300 signalling and TGF-beta in scleroderma fibroblasts. They are preclinical studies of disease mechanisms and do not test chloramphenicol. No established mechanistic connection links a bacterial ribosome inhibitor to fibrotic signalling.
The high score is therefore a computational prediction only. Chloramphenicol’s haematological toxicity is also a concern in a chronic autoimmune and fibrotic condition.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 8702443 | 1996 | Basic research | Arthritis and Rheumatism | Transcriptional regulation of the alpha1(I) procollagen gene in dermal fibroblasts from patients with recent-onset diffuse systemic sclerosis; role of intronic sequences |
| 9811061 | 1998 | Basic research | Arthritis and Rheumatism | Promoter elements and transcription factors behind up-regulated alpha1(I) procollagen expression in systemic sclerosis |
| 11229480 | 2001 | Basic research | Arthritis and Rheumatism | Blocking endogenous TGF-beta signalling prevents up-regulated collagen synthesis in scleroderma fibroblasts |
| 16319104 | 2006 | Basic research | Rheumatology (Oxford) | Constitutively phosphorylated Smad3 interacts with Sp1 and p300 in scleroderma fibroblasts |
None of these studies evaluates chloramphenicol.
India Market Information
At least 20 valid single-ingredient licences are recorded and the list may be partial. Main examples:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 19864 | Actimycetin Suspension | Suspension, bottle of 50 ml | Not recorded |
| 3564 | Anchlor-DX Eye Ointment | Eye ointment, tube of 5 gm | Not recorded |
| 104582 | Hytan C Eye Ointment | Eye ointment, tube of 5 gm | Not recorded |
| 13543 | Armycetin Capsule | Capsule, packet of 100 | Not recorded |
| 120346 | Kidopalm 125mg Syrup | Syrup, bottle of 50 ml | Not recorded |
Safety Considerations
- Disease-level cautions: Chloramphenicol is recorded as contraindicated or to be used with caution in patients with several conditions, including kidney disease, liver disease, thrombocytopenia, anaemia, aplastic anaemia, agranulocytosis, neutropenia, peripheral neuropathy, optic neuritis, acute intermittent porphyria and paroxysmal nocturnal haemoglobinuria. These are not taken from label text, so please confirm against the package insert.
- Drug Interactions: 478 interactions are recorded. Major-level interactions include cisapride and naloxegol. Moderate-level examples include sulfonylureas (glimepiride, glipizide, glyburide, chlorpropamide, acetohexamide), repaglinide, saxagliptin, rosuvastatin, simvastatin, metronidazole, budesonide, aprepitant, eliglustat, iron, balsalazide, naldemedine and nitisinone.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone. There are no clinical trials, the only publications are basic research that does not involve chloramphenicol, and there is no plausible mechanism linking a bacterial ribosome inhibitor to scleroderma fibrosis. The known bone-marrow toxicity adds a safety concern for a chronic condition.
To proceed, the following is needed:
- Mechanism-of-action data and a plausible biological rationale for fibrotic disease
- Preclinical studies testing chloramphenicol directly in scleroderma models
- Package insert warnings and contraindications from the local licence holders
- A benefit-risk assessment addressing haematological toxicity in a chronic autoimmune condition
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.