Ciprofloxacin
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Ciprofloxacin: From Bacterial Infections to Diffuse Scleroderma
One-Sentence Summary
Ciprofloxacin is a fluoroquinolone antibacterial, marketed in South Africa as tablets and drops. The TxGNN model predicts it may help in diffuse scleroderma, but this is a research-stage idea. There are 0 registered clinical trials and 2 publications for it, one of which reports a small controlled trial of ciprofloxacin as an antifibrotic in scleroderma skin.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA registration data provided; ciprofloxacin is a fluoroquinolone antibacterial |
| Predicted New Indication | Diffuse scleroderma |
| TxGNN Prediction Score | 99.87% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 8 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the source record. Ciprofloxacin is a fluoroquinolone antibacterial. Its established role is treating bacterial infections, and it has no known primary action on autoimmune or fibrotic disease.
Two indirect links are suggested by the retrieved literature:
- Antifibrotic effect on skin. A 2010 study proposed that oral ciprofloxacin might reduce skin fibrosis in scleroderma.
- Bacterial overgrowth. Systemic sclerosis can involve small bowel bacterial overgrowth, which causes diarrhoea, weight loss and malabsorption. An antibiotic could plausibly treat that complication. This would be treatment of a complication, not of the underlying disease.
Neither link shows clinical efficacy. The very high TxGNN score comes from knowledge-graph patterns and is not clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 20507401 | 2010 | Controlled, double-blind randomized clinical trial (per abstract) | J Dermatol | Tested whether oral ciprofloxacin reduces scleroderma severity, as an antifibrotic in skin. The abstract available here is truncated, so results and sample size could not be verified. |
| 7728404 | 1995 | Diagnostic study | Br J Rheumatol | 24 systemic sclerosis patients with malabsorption symptoms were assessed for small bowel bacterial overgrowth. It is a detection-methods paper, and the available text gives no ciprofloxacin efficacy data. |
South Africa Market Information
Ciprofloxacin has 8 SAHPRA registrations. Five are listed below. The registration data supplied has no approved-indication text, and it does not show Essential Medicines List (EML) status.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 35/20.1.1/0101 | Orpic | Tablet | Not listed in the data provided |
| A40/15.1/0048 | Ceprolen 5ml | Drops | Not listed in the data provided |
| 36/20.1.1/0377 | Ciploxx 500 | Tablet | Not listed in the data provided |
| 49/16.2/0071 | Xindex | Drops | Not listed in the data provided |
| A40/20.1.1/0372 | Biofloxx 500 | Tablet | Not listed in the data provided |
Dosage forms across the registrations include oral tablets, drops and an infusion.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
No drug interaction records were found for this drug in the source data.
Conclusion and Next Steps
Decision: Hold
Rationale: The support for diffuse scleroderma is a model prediction plus one small controlled study whose results could not be verified. There are no registered trials, and safety information for South Africa is missing. This is a research question, not a candidate for clinical use.
To proceed, the following is needed:
- Retrieve the full text of PMID 20507401 to confirm design, sample size, outcomes and effect size.
- Download the SAHPRA package insert for warnings, contraindications and interactions. This is required before any safety screening.
- Obtain mechanism of action data, for example from DrugBank, to assess the antifibrotic hypothesis.
- Weigh the known fluoroquinolone risks (for example, peripheral neuropathy) against any benefit in a chronic condition.
- Consider prioritising a different prediction for this drug: septicemic plague (L2 evidence, recommended Proceed with Guardrails). It has a completed Phase 2 randomized trial and several plague trials of ciprofloxacin. Its data focus on bubonic plague, so extrapolation to septicemic disease would need confirmation.
This report is for research reference only and does not constitute medical advice. Predicted indications require clinical validation before any use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.