A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline Versus Ceftriaxone.
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).



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.



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.



The results of this study suggest that ceftaroline fosamil may be an important treatment option for pediatric patients hospitalized with CABP.
From 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.
Christopher R
CR
Cannavino
Agnes
A
Nemeth
Bartosz
B
Korczowski
John S
JS
Bradley
Tanya
T
O'Neal
Alena
A
Jandourek
H David
HD
Friedland
Sheldon L
SL
Kaplan
D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002443:Ceftriaxone / Q000008:administration & dosage* / Q000009:adverse effects; D002511:Cephalosporins / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D011446:Prospective Studies; D013211:Staphylococcus aureus / Q000187:drug effects; D016896:Treatment Outcome; D000097583:Ceftaroline
D000900:Anti-Bacterial Agents; D002443:Ceftriaxone; D002511:Cephalosporins; D000097583:Ceftaroline