Ciprofloxacin
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Ciprofloxacin: Diffuse scleroderma
One-Sentence Summary
Ciprofloxacin is a fluoroquinolone antibiotic that acts against a range of bacterial infections. The TxGNN model predicts it may be useful for diffuse scleroderma, but there are no registered clinical trials and only 2 publications, so this remains a model prediction with weak, indirect support.
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 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Detailed mechanism of action data is not otherwise available in the data compiled for this report.
Any link to scleroderma is indirect. Two routes are plausible: treating small bowel bacterial overgrowth, which is common in systemic sclerosis, and a proposed antifibrotic effect in the skin. No direct disease-modifying mechanism has been established, and the very high model score is not backed by clinical data.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 20507401 | 2010 | Exploratory study (design not confirmed from the available text) | The Journal of Dermatology | Examined whether oral ciprofloxacin acts as an antifibrotic in the skin of patients with scleroderma. The abstract describes a controlled, double-blind randomised trial, but the results are not available in the data compiled for this report. |
| 7728404 | 1995 | Cohort/diagnostic | British Journal of Rheumatology | Small bowel bacterial overgrowth in 24 patients with systemic sclerosis and malabsorption symptoms; addresses a complication rather than the underlying disease. |
Evidence level is set at L5 because the cited studies do not allow a reliable conclusion on the effect of ciprofloxacin on diffuse scleroderma itself. The 2010 study’s outcome is not available, and the 1995 study concerns a complication.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 1208N | C-Flox 250 | Tablet 250 mg (as hydrochloride) | Not stated in the data compiled for this report |
Safety Considerations
- Drug Interactions: 100 interactions were recorded. Major-level interactions include hydrocortisone, triamcinolone, dexamethasone, betamethasone and bupropion. Moderate-level interactions include acarbose, famotidine, metformin, pioglitazone, loperamide, aprepitant, acetylsalicylic acid and budesonide.
Please also refer to the TGA-approved Product Information (PI) for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high, but no clinical trial studies ciprofloxacin in diffuse scleroderma, and the two available publications are exploratory or address a complication. The evidence does not yet justify moving forward.
To proceed, the following is needed:
- Full results of the 2010 randomised study of ciprofloxacin in scleroderma skin, with independent confirmation
- Mechanism of action data to clarify any antifibrotic effect
- Review of the TGA Product Information for warnings and contraindications, with particular attention to tendon, neuropathy and QT-related risks in a scleroderma population
- A safety plan for long-term use, given the many recorded drug interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.