Basilea Pharmaceutica Ltd. Logo
 

Ceftobiprole

 
 
Ceftobiprole: a broad-spectrum i.v. antibiotic Ceftobiprole  is a broad-spectrum antibiotic from the cephalosporin class for i.v. administration with bactericidal activity against certain Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp. Ceftobiprole is approved for sale in 13 European countries1 and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).2 The drug is currently commercialized in Germany, Italy, the United Kingdom, France, Austria and Switzerland.

Ceftobiprole is not approved in the United States. The drug received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) for the potential treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). In April 2016, Basilea signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), a division within the 'Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, the clinical phase 3 development of ceftobiprole to potentially gain regulatory approval in the United States.3
 
About hospital-acquired and community-acquired pneumonia
Hospital-acquired pneumonia (HAP) is one of the most common hospital-acquired infections and has been shown to have among the highest mortality rates of all hospital-acquired infections.4 Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most frequent causes of hospital-acquired pneumonia.5 Community-acquired pneumonia (CAP) is a common condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics.6 Prompt empiric intervention with an appropriate broad-spectrum antibiotic treatment is considered a best medical practice. The increasing incidence of bacteria resistant to many established antibiotics is a major concern.
 
About MRSA
Methicillin-resistant Staphylococcus aureus (MRSA) is a Gram-positive bacterium and an important cause of pneumonia, accounting for more than 20% of HAP cases.7 It is one of the most important causes of antibiotic-resistant healthcare-associated infections worldwide.8 With MRSA rates remaining above 25% in seven of the 30 reporting European Union/European Economic Area countries and a populations-weighted mean of 17.8%, the ECDC considers MRSA a public health priority.8 In the US, MRSA was assigned "threat level serious" by the US Centers for Disease Control and Prevention (CDC). For 2011, the CDC reported that approximately 80,000 invasive MRSA infections occurred in the US, resulting in 11,000 deaths.9

References

  1. Ceftobiprole has received national licenses for the treatment of adult patients with community- and hospital-acquired pneumonia, excluding ventilator-associated pneumonia, in Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Norway, Spain, Sweden, Switzerland and the United Kingdom. Ceftobiprole is not approved in the USA.
  2. UK Summary of Product Characteristics; [Accessed: September 26, 2016]
  3. Contract No. HSO100201600002C
  4. C. Rotstein et al. Clinical practice guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of Infectious Diseases & Medical Microbiology 2008 (19), 19-53
  5. R. N. Jones. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clinical Infectious Diseases 2010 (51), S81-S87
  6. W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care Clinics 2013 (29), 563-601
  7. E. Rubinstein et al. Pneumonia caused by methicillin-resistant Staphylococcus aureus. Clinical Infectious Diseases 2008 (46), Suppl 5, S378-S385
  8. European Centre for Disease Prevention and Control. Antimicrobial resistance surveillance in Europe 2012. Annual Report of the European Antimicrobial Resistance Surveillance Network (EARS-Net). ECDC 2013
  9. US Centers for Disease Control and Prevention (CDC). Antibiotic resistance threats in the United States, 2013. [Accessed September 26, 2016]
 
Info
 
 
 

Ceftobiprole –
Tests for Microbiology Labs
 
IDSA – Infectious
Diseases Society of America