Ciprofloxacin
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Ciprofloxacin: Diffuse scleroderma
Note: with English as the page language, the name is written once: diffuse scleroderma.
One-Sentence Summary
Ciprofloxacin is a fluoroquinolone antibiotic used against bacterial infections. The TxGNN model predicts it may be effective for diffuse scleroderma, with no registered clinical trials and 2 publications currently touching this direction, only one of which studies ciprofloxacin in scleroderma skin disease directly.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Diffuse scleroderma |
| TxGNN Prediction Score | 0.9987 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs on record: at least 20) |
| Number of DINs | 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. Ciprofloxacin belongs to the fluoroquinolone class of antibacterials, and its established role is anti-infective.
For diffuse scleroderma, two possible links appear in the literature. First, a 2010 controlled, double-blind randomized study (PMID 20507401) examined oral ciprofloxacin as an antifibrotic agent in scleroderma skin, possibly acting through effects on fibroblast activity or collagen metabolism. Second, small bowel bacterial overgrowth is common in systemic sclerosis (PMID 7728404), and an antibacterial could help with that complication. The second is a supportive-care rationale and not disease modification.
The evidence is thin: the antifibrotic study’s abstract is truncated in the data compiled, so its design and results need verification.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 20507401 | 2010 | Controlled, double-blind randomized trial (per abstract; classification to be verified) | The Journal of Dermatology | Tested whether oral ciprofloxacin reduces scleroderma severity and acts as an antifibrotic in skin; results not available in the excerpt |
| 7728404 | 1995 | Cohort / diagnostic study | British Journal of Rheumatology | 24 systemic sclerosis patients with malabsorption symptoms assessed for small bowel bacterial overgrowth and response to treatment |
Canada Market Information
The list below may be partial. Ciprofloxacin has 20 valid single-ingredient licences in Canada; no indication text, dosage form or manufacturer is recorded for them in the local data. Main examples:
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02492008 | NRA-CIPROFLOXACIN | Not available | Not available |
| 02303736 | TARO-CIPROFLOX | Not available | Not available |
| 02387131 | SANDOZ CIPROFLOXACIN | Not available | Not available |
| 02248756 | SANDOZ CIPROFLOXACIN | Not available | Not available |
| 01945270 | CILOXAN | Not available | Not available |
Safety Considerations
- Drug Interactions: 100 interactions are recorded. Major-level examples include hydrocortisone, dexamethasone, betamethasone, triamcinolone and bupropion. Moderate-level examples include metformin, pioglitazone, acarbose, famotidine, loperamide and acetylsalicylic acid.
- Conditions of concern: Conditions linked to ciprofloxacin as risks include long QT syndrome, torsades de pointes, epilepsy, kidney disease, myasthenia gravis, tendinitis, peripheral neuropathy and Clostridium difficile colitis. These come from relationship data, not label text.
Please also refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high (0.9987), but the only direct study of ciprofloxacin in scleroderma is a single small trial of uncertain design and unknown outcome, and no clinical trials are registered. The bacterial overgrowth angle is supportive care only.
To proceed, the following is needed:
- Retrieve and appraise the full text of PMID 20507401 (design, size, outcomes)
- Mechanism of action data to assess the antifibrotic hypothesis
- Package insert warnings and contraindications from Health Canada
- A risk-benefit review given tendon, neuropathy and QT-related risks in a chronic autoimmune population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.