Efficacy and safety of a decision rule for using antibiotics in children with pneumonia and vaccinated against pneumococcus. A randomized controlled trial

Arch Argent Pediatr. 2015 Oct;113(5):397-403. doi: 10.5546/aap.2015.eng.397.
[Article in English, Spanish]

Abstract

Introduction: Although most cases of pneumonia in children younger than 5 years old have a viral nature, in everyday practice, they are frequently treated with antibiotics. A clinical decision rule (BPS:Bacterial Pneumonia Score) proved to be effective for identifying which children with pneumonia required antibiotics, but its performance has not been assessed in the population vaccinated against pneumococcal disease. Our objective was to assess whether using the BPS would allow to reduce antibiotic use compared to routine management of children with community acquired pneumonia vaccinated against pneumococcal disease.

Material and methods: Randomized, controlled, partially-blinded clinical trial with parallel groups comparing two approaches in the management of children aged 3-60 months old in an outpatient setting because of pneumonia, who had been vaccinated with the pneumococcal conjugate vaccine.The BPS group received antibiotics with a BPS >4 points; while the control group was administered antibiotics at the discretion of the treating physician. The estimated sample size was calculated as, at least, 30 patients per group. The rate of antibiotic use and the clinical course were compared in both groups.

Results: Sixty-five patients (33 in the BPS group and 32 in the control group) were included; their average age was 17.5 months old. Antibiotic use was significantly higher in the control group than in the BPS group (21/32 versus 9/33; OR: 5.09; 95% CI: 1.57-16.85; p= 0.001). Seven patients had an unfavorable course (three in the BPS group, and four in the control group).

Conclusion: The use of the BPS allowed to reduce antibiotic use in the initial management of patients with pneumonia vaccinated against pneumococcal disease, without increasing the probability of an unfavorable course of the disease.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Child, Preschool
  • Clinical Decision-Making*
  • Female
  • Humans
  • Infant
  • Male
  • Pneumococcal Infections / prevention & control
  • Pneumococcal Vaccines
  • Pneumonia, Bacterial / drug therapy*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Pneumococcal Vaccines