Clavulanic Acid
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Clavulanic Acid
- Clavulanic Acid: From Beta-Lactamase Inhibition in Bacterial Infections to Ureaplasma Urethritis
Clavulanic Acid: From Beta-Lactamase Inhibition in Bacterial Infections to Ureaplasma Urethritis
One-Sentence Summary
Clavulanic acid is a beta-lactamase inhibitor, usually paired with amoxicillin to treat bacterial infections. The TxGNN model predicts it may be effective for Ureaplasma urethritis, but there are 0 clinical trials and 0 publications for this indication, so the prediction rests on the model score alone. The prediction is also mechanistically implausible, because Ureaplasma has no cell wall.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registration data provided; known use is as an amoxicillin partner in bacterial infections |
| Predicted New Indication | Ureaplasma urethritis |
| TxGNN Prediction Score | 99.93% |
| Evidence Level | L5 (model prediction only) |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 14 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Based on known pharmacology, clavulanic acid is a beta-lactamase inhibitor. It protects partner beta-lactam antibiotics, mainly amoxicillin, from being broken down by bacterial enzymes.
This mechanism does not fit Ureaplasma urethritis. Ureaplasma species have no cell wall, so beta-lactam antibiotics have no target to act on, and protecting one from beta-lactamase adds nothing. The high score (99.93%) is therefore not supported by known pharmacology. It probably reflects the drug’s close association with many infection-related diseases in the knowledge graph.
The other top predictions show the same pattern. Gonococcal urethritis, uterine inflammatory disease and urogenital tuberculosis have a plausible bacterial or beta-lactamase link. Several others, such as abdominal cystic lymphangioma and celiac trunk compression syndrome, have no plausible link at all and are probably model artifacts.
Clinical Trial Evidence
Currently no related clinical trials registered for Ureaplasma urethritis. No SANCTR or PACTR entries were provided.
Literature Evidence
Currently no related literature available for Ureaplasma urethritis.
Other Predicted Indications Reviewed
| Rank | Predicted Indication | Score | Evidence Level | Assessment |
|---|---|---|---|---|
| 2 | Gonococcal urethritis | 99.93% | L5 | Plausible: inhibiting beta-lactamase could restore amoxicillin activity against penicillinase-producing N. gonorrhoeae. Resistance patterns and current guidelines limit relevance. Research question |
| 3 | Uterine inflammatory disease | 99.92% | L5 | Plausible: polymicrobial pelvic infections may involve beta-lactamase-producing bacteria. No evidence provided |
| 4 | Xanthogranulomatous pyelonephritis | 99.90% | L5 | Antibacterial use is conceptually plausible, but management is mainly surgical. No evidence provided |
| 5 | Urogenital tuberculosis | 99.89% | L4 | One case report (PMID 26847806, 2016, BMJ Case Reports) in which amoxicillin/clavulanic acid was given before tuberculous epididymo-orchitis was diagnosed. It appears to describe a diagnostic mimic, not a treatment benefit |
| 6-10 | Abdominal cystic lymphangioma, celiac trunk compression syndrome, abdominal ectopic pregnancy, lymph node palisaded myofibroblastoma, disease of uterine broad ligament | 99.79-99.80% | L5 | No plausible antibacterial mechanism. The one linked trial (NCT04751500, hysteroscopic miscarriage management) does not test clavulanic acid and is not supporting evidence |
South Africa Market Information
The registration data supplied does not include approved-indication text or manufacturers. Essential Medicines List (EML) status was not provided.
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| Reg. No. 50/20.1.2/0659 | Co-Amoxiclaz S Unimed | Suspension |
| Reg. No. 41/20.1.2/0977 | Gulf amoxy co powder for injection vial | Injection |
| Reg. No. 37/20.1.2/0674 | Augmaxcil vial 20ml | Injection |
| Reg. No. 45/7.1.5/0874 | Raviag | Tablet |
| Reg. No. 36/7.1.3/0114 | Simayla Lisinopril 20 | Tablet |
The last two products, Raviag and Simayla Lisinopril 20, do not look like amoxicillin/clavulanic acid products (the second name refers to lisinopril). These entries need checking against the SAHPRA register before use.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The top prediction has no trials or literature, and it conflicts with known pharmacology because Ureaplasma lacks a cell wall. Safety data from the SAHPRA package insert is also missing, which blocks safety screening.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications (download and parse the PI)
- Mechanism of action data from DrugBank (DB00766)
- Verification of the registration entries that do not look like clavulanic acid products
- For a more credible follow-up, prioritise gonococcal urethritis and uterine inflammatory disease. Both need a literature search and a check against current South African treatment guidelines and local resistance data
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.