Ceftobiprole medocaril sodium

Table of contents

• What is ceftobiprole medocaril sodium?
• How does ceftobiprole medocaril sodium work?
• Which conditions is ceftobiprole medocaril sodium used or studied for?
• How is ceftobiprole medocaril sodium given?
• What do the clinical trials show?
• What side effects are known?

What is ceftobiprole medocaril sodium?

Ceftobiprole medocaril sodium is a chemically synthesised antibiotic belonging to the cephalosporin class. It is classified as a fifth-generation cephalosporin with broad-spectrum activity against Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant strains.^[5] The substance appears under the trade name Mabelio in the EU Clinical Trials Information System, and the same active substance is known as Zevtera in other regulatory contexts.^[4] Other names for the substance include BAL5788, Ro 65-5788, and BAL9141, with ceftobiprole medocaril being a prodrug form.^[3] According to the registry records, ceftobiprole medocaril sodium is already authorised as a medicine in France, with the authorisation held by Correvo.^[1]

How does ceftobiprole medocaril sodium work?

Ceftobiprole medocaril sodium is a prodrug that is converted in the body to the active substance ceftobiprole. As a cephalosporin antibiotic, it works by interfering with bacterial cell wall synthesis, which leads to the death of susceptible bacteria. Its broad-spectrum activity includes coverage against Gram-positive organisms such as MRSA, which are resistant to many other beta-lactam antibiotics.^[5] The molecular structure of ceftobiprole medocaril has a molecular weight of 690.66 and the formula C26H26N8O11S2.^[3]

Which conditions is ceftobiprole medocaril sodium used or studied for?

The registered trial in the EU Clinical Trials Information System studies ceftobiprole medocaril sodium in one condition:

• Osteoarticular infections on implanted material — infections affecting bone and joint tissue around prosthetic devices such as artificial joints, where the trial compares how different antibiotic treatments affect the gut microbiota.^[1]

The therapeutic area for the substance in the registry is bacterial infections and mycoses.^[1] As a broad-spectrum cephalosporin, its antimicrobial activity is relevant to serious infections caused by resistant Gram-positive bacteria, including MRSA.^[5]

How is ceftobiprole medocaril sodium given?

Ceftobiprole medocaril sodium is given as a solution for infusion by the intravenous route. In the registered trial, the product Mabelio 500 mg powder for solution for dilution for infusion is administered at a dose of 1.5 grams intravenously.^[1] The pharmaceutical form recorded in the registry is a solution for infusion, and the route of administration is intravenous perfusion use.^[1] The NHS dm+d browser lists the product as ceftobiprole 500 mg powder for solution for infusion vials.^[2]

What do the clinical trials show?

One clinical trial is registered in the EU Clinical Trials Information System for ceftobiprole medocaril sodium. The trial, identified as 2024-513298-29-00, is a Phase 2 interventional study with 75 participants.^[1] It is currently authorised but has not reported results.

The trial investigates osteoarticular infections on implanted material. Its primary outcome is the biodiversity of the gut microbiota, determined from high-throughput sequencing of bacterial 16S rDNA. The study compares the evolution of gut microbiota biodiversity between day 1 and day 5 in participants treated with ceftobiprole, cefepime plus daptomycin, or piperacillin-tazobactam plus daptomycin.^[1]

The study is designed to assess how different antibiotic regimens affect the digestive microbiota in the context of suspected osteoarticular infection on material. Ceftobiprole medocaril sodium appears as the test substance in this trial, meaning it is the medicine being investigated.^[1]

What side effects are known?

The supplementary sources provided do not contain a specific list of side effects for ceftobiprole medocaril sodium. As a cephalosporin antibiotic, it belongs to a class of medicines that can cause allergic reactions and gastrointestinal disturbances, but no specific side effect data are available from the sources included on this page. The registered trial measures the impact of treatment on the gut microbiota, which may provide information about gastrointestinal effects in the future.^[1]