Impact of a multiplex respiratory PCR panel on antibiotic stewardship in hospitalized pediatric pneumonia: a randomized clinical trial.

UNLABELLED: We aimed to evaluate whether the FILMARRAY® Pneumonia Panel (FAPP) added to standard care could effectively guide antibiotic prescriptions in hospitalized pediatric patients with infectious pneumonia. In this single-center, open-label, parallel-group randomized controlled clinical trial, we enrolled hospitalized children (28 days to 18 years old) diagnosed with infectious pneumonia. Participants were randomized to standard care only (control) or to added FAPP (intervention group). The primary outcome was the proportion of patients with antibiotic change within 72 h. Between December 8, 2021, and February 16, 2023, we enrolled 315 patients (157 in the intervention group and 158 in the control group). Pathogens were detected in 86.6% (32.7% bacterial, 56.5% viral, and 10.9% atypical) via FAPP, which may encompass colonizing organisms due to its enhanced sensitivity. The primary outcome was comparable between the intervention and control groups (51.6%, 81/157, versus 49.4%, 78/158; P = 0.693). However, key exploratory secondary outcomes demonstrated significant improvements in the intervention group: total frequency of changes in antibiotic and antiviral agents based on pathogen results (47.8%, 75/157, versus 25.3%, 40/158; P < 0.001) and proportion of patients with antibiotic de-escalation within 72 h (14.6%, 23/157, versus 1.9%, 3/158; P < 0.001).

CONCLUSION

Integrating FILMARRAY® into pediatric pneumonia clinical management did not significantly boost initial overall antibiotic modification rates. However, exploratory analysis showed it improved targeted antimicrobial adjustments and facilitated antibiotic de-escalation, suggesting FILMARRAY® may add value to antibiotic stewardship. Subsequent trials could substantiate this theoretical proposition.

TRIAL REGISTRATION: Chictr.org.cn, ChiCTR2100047213, registered 11 June 2021-prospectively registered, https://www.chictr.org.cn/showproj.html?proj=128024 .

WHAT IS KNOWN: • FILMARRAY® molecular techniques, via semiquantitative analysis to identify potential pathogens, may contribute to reduce antibiotic usage and facilitate more targeted and appropriate antibiotic therapy in adult patients with lower respiratory tract infections.

WHAT IS NEW: • Integrating FILMARRAY® into pediatric pneumonia care did not notably raise initial overall antibiotic modification rates. However, exploratory analysis showed it improved targeted antimicrobial adjustments and promoted antibiotic de-escalation, suggesting potential value for antibiotic stewardship.