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A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline
Christopher R Cannavino1, Agnes Nemeth, Bartosz Korczowski
1From the *Division of Infectious Diseases, Department of Pediatrics, University of California at San Diego and Rady Children's Hospital, San Diego, California; †Faculty of Medicine, 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary; ‡Medical College, University of Rzeszow, Rzeszow, Poland; §Department of Clinical Development, Cerexa, Inc., Oakland, California; and; ¶Section of Pediatric Infectious Diseases, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Feigin Center, Houston, Texas.
Insights
Ceftaroline fosamil is a safe and effective antibiotic for treating pediatric community-acquired bacterial pneumonia (CABP). It demonstrated comparable effectiveness to ceftriaxone in a clinical study, offering a potential new option for children with CABP.
Area of Science:
- Pediatric Infectious Diseases
- Antibiotic Therapy
- Clinical Pharmacology
Background:
- Community-acquired bacterial pneumonia (CABP) remains a significant pediatric infection despite vaccination.
- Ceftaroline fosamil is a broad-spectrum cephalosporin effective against resistant bacteria like Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus (MRSA).
Purpose of the Study:
- To evaluate the safety, tolerability, and effectiveness of ceftaroline fosamil in pediatric patients hospitalized with CABP.
- To compare ceftaroline fosamil with ceftriaxone in this patient population.
Main Methods:
- A randomized, active-controlled, observer-blinded clinical study involving pediatric patients with CABP.
- Patients were stratified by age and randomized to receive intravenous ceftaroline fosamil or ceftriaxone.
- Clinical outcomes, adverse events, and microbiologic responses were assessed.
Main Results:
- Ceftaroline fosamil was well tolerated, with similar rates of treatment-emergent adverse events compared to ceftriaxone.
- High clinical cure rates were observed for both ceftaroline fosamil (88%) and ceftriaxone (89%).
- The study successfully treated S. aureus infections, including one MRSA case, with ceftaroline fosamil.
Conclusions:
- Ceftaroline fosamil demonstrated comparable effectiveness and safety to ceftriaxone for pediatric CABP.
- Ceftaroline fosamil represents a promising treatment option for hospitalized children with CABP, including those with resistant pathogens.
Background:
Community-acquired bacterial pneumonia (CABP) remains a major infection among children, despite the use of pneumococcal vaccination. Ceftaroline fosamil is a broad-spectrum cephalosporin antibiotic with activity against many bacteria, including Streptococcus pneumoniae (both penicillin-nonsusceptible and multidrug-resistant strains) and Staphylococcus aureus (including methicillin-resistant S. aureus). This article describes the safety, tolerability, and effectiveness of ceftaroline fosamil in the treatment of pediatric patients hospitalized with CABP, from a randomized, active-controlled, observer-blinded clinical study (registration number NCT01530763).
Methods:
Pediatric patients were stratified into 4 age cohorts and randomized (3:1) to receive either intravenous ceftaroline fosamil or ceftriaxone, with optional oral switch for a total treatment duration of 5-14 days. Enrollment was planned for 160 patients. Data collected included demographics, infection characteristics and pathogens. Treatment-emergent adverse events, clinical outcomes, and microbiologic responses were assessed.
Results:
Ceftaroline fosamil was well tolerated. Similar percentages of patients in the ceftaroline fosamil (55/121; 45%) and ceftriaxone (18/39; 46%) groups reported treatment-emergent adverse events. Coombs seroconversion was observed in 17% of patients in the ceftaroline fosamil group; however, no evidence of hemolytic anemia or hemolysis was found. No deaths were reported during the study. Ceftaroline fosamil had similar effectiveness to ceftriaxone, with high clinical cure rates at test-of-cure in the modified intent-to-treat population (94/107; 88% and 32/36; 89%, respectively). Three documented S. aureus infections were successfully treated in the ceftaroline group, including one caused by methicillin-resistant S. aureus.
Conclusions:
The results of this study suggest that ceftaroline fosamil may be an important treatment option for pediatric patients hospitalized with CABP.
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