These Phase 3 trials evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to seven to ten days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA.
These two SOLO studies were conducted in 1,959 patients (modified intent-to-treat population, or mITT), with 405 of the patients suffering from a cSSTI with a documented MRSA infection, concluded the company.
In cases of multiple infections, investigators entered the type of infection in order of clinical significance (in order of most to least severe): endocarditis, osteomyelitis, bacteremia, other [CNS infection, foreign body/prosthetic infection, metastatic abscess, necrotizing fasciitis, necrotizing infection, surgical/non-surgical antibiotic prophylaxis, septic arthritis and urinary tract infection/pyelonephritis], cSSTI, and uncomplicated skin and soft tissue infection.
This trial reflects the experience of six Brazilian sites with daptomycin, which is used to treat cSSTI due to Gram-positive bacteria and SAB (S.
The most common infection sites for the uncomplicated SSTI group were the extremities (32%) and buttocks or perineum (27%), while the most common infection sites for the cSSTI
group were the face or neck (39%) and extremities (24%).
These studies demonstrated consistent clinical efficacy in the treatment of cSSTI
and CAP with the recognised tolerability profile of the cephalosporin class.
It is also not an appropriate empiric option as monotherapy for the treatment of patients with cSSTI
Cure rates according to underlying co-morbidity and concomitant baseline bacteraemia in the clinically evaluable population in cases of cSSTI
are depicted in Fig.
The company added that cSSTI
is caused by susceptible Gram-positive microorganisms, including Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species.
The emergence of drug-resistant bacteria causing CAP and cSSTI
has increased the potential for inappropriate initial therapy in these infections.
As such, we look forward to working with the EMEA to make oritavancin available throughout the European Union for the treatment of cSSTI
in a timely manner.
The filing included data from two pivotal Phase 3 clinical trials conducted by Cubist that examined the safety and efficacy of CUBICIN in the treatment of cSSTI