Sulbactam
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Sulbactam: Bacterial arthritis
One-Sentence Summary
Sulbactam is a beta-lactamase inhibitor, originally used against infections such as staphylococcal and Escherichia coli infections and cholangitis. The TxGNN model predicts it may be effective for bacterial arthritis, but there are no registered clinical trials and the literature consists of 19 publications (mostly case reports, in vitro studies and a few older small clinical studies).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Bacterial arthritis |
| TxGNN Prediction Score | 0.9979 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (10 of 10) – CDSCO approval status is not included in this data |
| Number of Listed Products | 10 (valid: 10) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on general pharmacology, sulbactam is an irreversible beta-lactamase inhibitor. It also has intrinsic activity against Acinetobacter baumannii through penicillin-binding protein (PBP) binding. When combined with ampicillin, it extends coverage to beta-lactamase-producing Staphylococcus aureus, E. coli and anaerobes.
These organisms are common causes of bone and joint infections. The original indications (staphylococcal and E. coli infections) therefore overlap with the likely pathogens of bacterial arthritis, so the link is biologically plausible.
The very high TxGNN score is consistent with this overlap. It is a computational prediction, not clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
The publications below are those most relevant to sulbactam and bacterial arthritis. Many others in the compiled set are about septic arthritis in general or other pathogens and do not test sulbactam.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 2677956 | 1989 | Randomized comparative study | Pediatr Infect Dis J | Ampicillin/sulbactam vs ceftriaxone in children with soft tissue infections (105), suppurative arthritis (11) and osteomyelitis (9) |
| 3026009 | 1986 | Open randomized comparative study | Rev Infect Dis | Sulbactam/ampicillin (13 patients) vs cefotaxime (9 patients) for bone, joint and soft-tissue infections; clinical cure or improvement reported in all 13 sulbactam/ampicillin patients |
| 3026018 | 1986 | Clinical study | Rev Infect Dis | Nine children with osteomyelitis and/or septic arthritis treated sequentially with parenteral sulbactam/ampicillin then oral sultamicillin; all identified pathogens were susceptible |
| 3252119 | 1988 | Clinical trial | Mikrobiyol Bul | 84 patients with various infections (including 5 with septic arthritis or osteomyelitis) treated with ampicillin and sulbactam |
| 9263167 | 1997 | Case report | J Rheumatol | Pasteurella multocida arthritis with gout after a cat bite, resolved with ampicillin/sulbactam, aspiration and intra-articular steroids |
| 1745624 | 1991 | In vitro comparison / review | Pharmacotherapy | Ampicillin-sulbactam vs ticarcillin-clavulanate: in vitro activity and clinical efficacy review |
| 36804370 | 2023 | Review | Int J Antimicrob Agents | Off-label use vs formal recommendations of antibiotics for multidrug-resistant bacterial infections |
| 39193962 | 2024 | Retrospective epidemiology | Clin Lab | Pathogen distribution and antimicrobial resistance in bone and joint infections in children under four |
| 33606293 | 2021 | In vitro / preclinical | Vet Surg | Cytotoxicity of antibiotics to canine chondrocytes and synoviocytes |
| 36550469 | 2022 | Case report | BMC Infect Dis | Hyperammonemia in a septic patient with Ureaplasma parvum arthritis |
The supporting clinical studies are small, old (1986–1989) and mostly paediatric. Several are open or of uncertain design and involve the ampicillin/sulbactam combination, not sulbactam alone.
India Market Information
Approved indication text is not recorded in the licence data. All 10 registrations are valid single-ingredient injections.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 20197 | Addbactam 2gm Injection (Fusion Healthcare) | Vial of 1 injection | Not recorded |
| 146022 | Marzon SB 2000mg Injection (Eris Lifesciences) | Vial of 1 injection | Not recorded |
| 207743 | Sulbamed 1000mg Injection (United Biotech) | Vial of 1 injection | Not recorded |
| 143500 | Marzon SB 1000mg Injection (Eris Lifesciences) | Vial of 1 injection | Not recorded |
| 205473 | Sulbamax 1gm Injection (Astaris Lifesciences) | Vial of 1 injection | Not recorded |
Safety Considerations
- Contraindication-related conditions (from the knowledge graph, not label text): kidney disease, pyoureter, Clostridium difficile colitis, perinatal necrotizing enterocolitis, infectious mononucleosis, chronic Epstein-Barr virus infection syndrome.
No drug interaction records were found. Please refer to the package insert for other safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is mechanistically plausible, and older small studies of ampicillin/sulbactam in bone and joint infections are supportive. However, there are no registered trials, the supporting studies are small, dated and involve the combination product, and the package insert safety data and MOA data are missing. This is best treated as a research question for now.
To proceed, the following is needed:
- Package insert warnings and contraindications from Indian regulatory sources (a blocking gap for safety screening)
- Mechanism of action data (for example, from DrugBank)
- Approved indication text for the Indian licences, to confirm whether bone and joint infections are already covered
- Review of the full text of the 1986–1989 comparative studies to confirm design and outcomes specific to septic arthritis
- Current susceptibility data for the main arthritis pathogens in India
- Route and dosing compatibility assessment for joint infection (sulbactam is available in India only as an injection)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.