A Multicenter, Randomized, Observer-blinded, Active-controlled Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Comparator in Pediatric Patients With Acute Bacterial Skin and Skin Structure Infection.

Abstract

BACKGROUND:

Ceftaroline has in vitro activity against bacterial isolates, including methicillin-resistant Staphylococcus aureus. This is the first study to investigate ceftaroline fosamil in pediatric patients with acute bacterial skin and skin structure infections (ABSSSIs).

METHODS:

A multicenter, observer-blinded study (NCT01400867) in pediatric patients (2 months-17 years of age) with ABSSSIs. Patients were randomized 2:1 to receive intravenous (IV) ceftaroline fosamil or IV comparator (vancomycin or cefazolin, plus optional aztreonam) with optional switch to oral antibacterials from Day 4. Safety and clinical outcomes were assessed.

RESULTS:

Of 163 enrolled patients, 159 received treatment. Treatment groups were comparable for baseline characteristics. Rates of study drug-related treatment-emergent adverse events were similar for ceftaroline fosamil [22% (23/106)] and comparator [23% (12/53)]. One serious adverse event, considered to be related to IV study drug, occurred in the ceftaroline fosamil group (hypersensitivity). In both the treatment groups, 85% (ceftaroline fosamil, 91/107 and comparator, 44/52) of the modified intent-to-treat population achieved early clinical response (≥20% reduction in infection area from baseline). Clinical cure rates at test-of-cure were high [ceftaroline fosamil, 94% (101/107) and comparator, 87% (45/52)]. For patients evaluated 8 to 15 days after the last dose of any antibiotic (IV or oral), from whom methicillin-resistant Staphylococcus aureus was initially isolated, a favorable microbiologic response (reflecting the efficacy of oral/IV therapy and capturing a relapse or reinfection) was achieved with ceftaroline fosamil [89% (16/18)] and comparator [57% (4/7)].

CONCLUSIONS:

Ceftaroline fosamil, with optional oral switch, was as well-tolerated and effective in pediatric patients with ABSSSIs as comparator therapy.

• Authors: Bartosz Korczowski, Tinatin Antadze, Manana Giorgobiani, Martin E Stryjewski, Alena Jandourek, Alexander Smith, Tanya O'Neal, John S Bradley
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 35 Issue 8 Pg. e239-47 (08 2016) ISSN: 1532-0987 [Electronic] United States
• PMID: 27164462 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Cephalosporins

Topics

• Acute Disease
• Adolescent
• Anti-Bacterial Agents (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Cephalosporins (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Child
• Child, Preschool
• Female
• Humans
• Infant
• Male
• Microbial Sensitivity Tests
• Skin Diseases, Bacterial (drug therapy)
• Staphylococcus aureus (drug effects)
• Streptococcus pyogenes (drug effects)
• Treatment Outcome
• Ceftaroline