A Multicenter, Randomized, Observer-blinded, Active-controlled Study Evaluating the Safety and Effectiveness of Ceftaroline Compared With Ceftriaxone Plus Vancomycin in Pediatric Patients With Complicated Community-acquired Bacterial Pneumonia.

Abstract

BACKGROUND:

The broad-spectrum cephalosporin ceftaroline, a metabolite of the prodrug ceftaroline fosamil, has shown in vitro activity against clinical isolates from pediatric patients.

METHODS:

This multicenter, randomized, observer-blinded, active-controlled study (NCT01669980) assessed the safety and effectiveness of ceftaroline fosamil compared with ceftriaxone plus vancomycin in patients between 2 months and 17 years of age with complicated community-acquired bacterial pneumonia. Patients were randomized 3:1 (stratified by age cohort) to receive either ceftaroline fosamil or ceftriaxone plus vancomycin (comparator) as intravenous therapy for ≥3 days. Patients who met specific study criteria on or after Study Day 4 were permitted to switch to an oral study drug. Safety assessments were treatment-emergent adverse events, and the effectiveness of treatment was assessed by clinical and microbiologic outcomes.

RESULTS:

The median duration of intravenous treatment was 9.0 (range, 3.0-19.0) days in the ceftaroline fosamil group (N=30) and 7.5 (5.0-13.0) days in the comparator group (N=10). At least one treatment-emergent adverse event was experienced by 12/30 patients (40%) in the ceftaroline fosamil group and 8/10 (80%) in the comparator group; most treatment-emergent adverse events in both groups were mild to moderate in intensity. Clinical response rates in the modified intent-to-treat population were 52% (15/29 patients) in the ceftaroline fosamil group and 67% in the comparator group (6/9); clinical stability at Study Day 4 was 21% (6/29) and 22% (2/9), respectively.

CONCLUSIONS:

Ceftaroline fosamil was well tolerated and showed similar clinical response rates to ceftriaxone plus vancomycin in pediatric patients with complicated community-acquired bacterial pneumonia.

• Authors: Jeffrey L Blumer, Tina Ghonghadze, Christopher Cannavino, Tanya O'Neal, Alena Jandourek, Hillel David Friedland, John S Bradley
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 35 Issue 7 Pg. 760-6 (07 2016) ISSN: 1532-0987 [Electronic] United States
• PMID: 27078119 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Cephalosporins
• Vancomycin
• Ceftriaxone

Topics

• Adolescent
• Anti-Bacterial Agents (administration & dosage, adverse effects)
• Ceftriaxone (administration & dosage, adverse effects)
• Cephalosporins (administration & dosage, adverse effects)
• Child
• Child, Preschool
• Community-Acquired Infections (complications, drug therapy)
• Female
• Humans
• Infant
• Infusions, Intravenous
• Male
• Pneumonia, Bacterial (complications, drug therapy)
• Treatment Outcome
• Vancomycin (administration & dosage, adverse effects)
• Ceftaroline