Publication date: Jun 23, 2025
Amoxicillin-clavulanate is commonly used to prevent infections following snakebites despite the lack of clinical evidence. We aimed to demonstrate that clinically directed initiation of amoxicillin-clavulanate would be non-inferior to routine use in this setting. Open-label, randomised, non-inferiority trial with blinded adjudication of endpoints. Emergency department of a teaching hospital in southern India. Adults with local swelling following snakebites within 24 hours of bite. In the routine use strategy, intravenous followed by oral amoxicillin-clavulanate was administered for at least 5 days. In the clinically directed strategy, the antibiotic was only initiated for clinical failures. Primary outcomes were protocol-defined clinical failure and total antibiotic consumption. Non-inferiority margin was prespecified as 10%. Secondary outcomes were the length of hospital stay, total antivenom consumption, new-onset organ failure, bleeding requiring transfusion, death/need for surgical intervention and drug-related adverse events. The trial was prematurely stopped due to the COVID-19 situation after randomising 66 patients-34 to clinically directed initiation and 32 to routine use arms. Russell’s viper was the most common (21 (32%)) biting snake species identified; 52 (79%) patients had evidence of haemotoxic envenomation at baseline, and 24 (36%) patients developed AKI. There were 10 clinical failures-six in the clinically directed initiation arm and four in the routine use arm. The difference in clinical failure between the two arms was 5. 2% (-12. 0%-21. 7%; p=0. 291); the upper bound of the CI exceeded the prespecified non-inferiority margin. Total antibiotic consumption, expressed in DDDs, was significantly lower in the clinically directed initiation arm (0 (0-1) vs 5. 31 (4. 67-6. 17); p
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Semantics
| Type | Source | Name |
|---|---|---|
| drug | DRUGBANK | Amoxicillin |
| drug | DRUGBANK | Clavulanic acid |
| disease | MESH | complications |
| disease | MESH | infections |
| disease | MESH | Emergency |
| disease | MESH | bleeding |
| disease | MESH | death |
| disease | IDO | intervention |
| disease | MESH | COVID-19 |
| disease | MESH | shock |
| disease | IDO | blood |
| disease | IDO | infection |
| disease | MESH | osteomyelitis |
| disease | MESH | pneumonia |
| disease | MESH | urinary tract infections |