Ceftriaxone
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Ceftriaxone: From Antibacterial Therapy to Hyperamylasemia
One-Sentence Summary
Ceftriaxone is a third-generation cephalosporin antibiotic. It is registered in South Africa as an injectable product. The TxGNN model predicts it may be effective for hyperamylasemia, but there are 0 clinical trials and only 3 publications, of which just one is loosely related. This is a model-only signal with no direct support, so the prediction is best treated as a research question.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Bacterial infections (ceftriaxone is a cephalosporin antibacterial). The SAHPRA registration data provided contain no approved-indication text. |
| Predicted New Indication | Hyperamylasemia |
| TxGNN Prediction Score | 99.39% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 6 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available in the record. Ceftriaxone is a third-generation cephalosporin that inhibits bacterial cell-wall synthesis by binding penicillin-binding proteins. Its efficacy in bacterial infection is well established.
Hyperamylasemia is a raised serum amylase level, a laboratory finding rather than an infection. There is no direct antibacterial rationale for treating it. The only relevant signal is a 1999 report on ceftriaxone prophylaxis after endoscopic papillosphincterotomy. In that setting, hyperamylasemia and post-procedure pancreatitis are complications, so any benefit would be indirect, through preventing biliary infection. The other two papers (a case report and a study of intracranial bleeding) do not involve ceftriaxone as a treatment for this condition. The high graph score is therefore unsupported by mechanism or clinical data.
Note: The best-supported prediction for ceftriaxone in this evidence pack is infectious otitis media. It has L1 evidence, including randomised trials of intramuscular ceftriaxone, and a “Proceed with Guardrails” rating. It is effectively an established use rather than a novel repurposing.
Clinical Trial Evidence
Currently no related clinical trials registered for hyperamylasemia (ClinicalTrials.gov, ICTRP, SANCTR and PACTR identifiers: none found).
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 10458061 | 1999 | Clinical study (comparative, 30 vs 30 patients; design not verifiable from title) | Bratisl Lek Listy | 1 g ceftriaxone prophylaxis after endoscopic papillosphincterotomy compared with no antibiotic. Bile isolates (mainly Pseudomonas aeruginosa and E. coli) were sensitive to ceftriaxone. The outcome data are truncated in the source, so the effect on hyperamylasemia cannot be confirmed. |
| 7522351 | 1994 | Observational | South Med J | 38 patients with intracranial bleeding: 25 had raised lipase and 17 also had raised amylase, without pancreatitis. Describes the phenomenon only, with no ceftriaxone involvement. |
| 36263834 | 2023 | Case report | Rev Esp Enferm Dig | Weil syndrome (leptospirosis) with upper gastrointestinal bleeding. Not relevant to ceftriaxone efficacy in hyperamylasemia. |
South Africa Market Information
Five of the six registrations are listed below. The registration data provided contain no approved-indication text or manufacturer names.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 47/20.1.1/1245 | Obkef 1G Injection | Injection | Not provided in registration data |
| Reg. No. 48/20.1.1/0228 | Ceftriaxone 1G Fksa | Injection | Not provided in registration data |
| Reg. No. 37/20.1.1/0042 | Adco Ceftriaxone Powder for Injection | Injection | Not provided in registration data |
| Reg. No. 37/20.1.1/0368 | Rociject Powder for Injection | Injection | Not provided in registration data |
| Reg. No. R/20.1.1/47 | Rocephin | Injection | Not provided in registration data |
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 99.39% model score is a prediction only. There are no clinical trials, and the sole related paper is a 1999 study of infection prophylaxis after a biliary procedure, where any effect on amylase would be indirect. Ceftriaxone has no plausible direct action on hyperamylasemia.
To proceed, the following is needed:
- A full read of the 1999 papillosphincterotomy study (PMID 10458061) to see whether hyperamylasemia or post-procedure pancreatitis rates differed between groups
- A prospective or controlled study in post-endoscopic biliary procedure patients, if this question is pursued
- SAHPRA Professional Information (warnings and contraindications) and detailed mechanism of action data
- If a South African repurposing case is wanted, prioritise infectious otitis media. It needs stewardship guardrails: reserve ceftriaxone for cases where oral therapy fails or is not feasible, and check it against local resistance data.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.