Efficacy and safety of clarithromycin in pediatric patients with upper respiratory infections: a systematic review with meta-analysis

Rev Invest Clin. 2012 Mar-Apr;64(2):126-35.


Purpose: Upper respiratory infections (URIs) are one of the most common infectious diseases in children. Macrolides had been considered one of the best options of treatment. Instead of clarithromycin is one of the macrolides most used, meta-analysis about the safety and efficacy of this drug has not been published.

Materials and methods: A systematic review with meta-analysis of randomized controlled trials (RCTs) was conducted. Studies in subjects < or = 12 years of age with URIs were included. Central Cochrane Registry, MEDLINE, EMBASE, Lilacs and Artemisa from 1966 to January of 2011 were reviewed. Clinical cure, clinical success, bacteriological eradication, relapse risk and adverse events risks were analyzed. Risks ratios (RR) with 95% confidence intervals (CI 95%) were calculated, using a fixed effects model.

Results: 24 studies, from a total of 76 RCTs were included. Clarithromycin was therapeutically equivalent to other antibiotics studied with respect to clinical cure [RR 1.02 (0.98 to 1.06), p NS], clinical success [RR 1.01 (0.99 to 1.03), p NS] and relapse risk [RR 1.34 (0.81 to 2.21), p NS], but was associated with a better bacteriological eradication [RR 1.06 (1.02 to 1.09), p 0.001], and a lower risk for related adverse events [RR 0.77 (0.65 to 0.90), p = 0.001].

Conclusions: High quality evidence showed that Clarithromycin is a safe and effective alternative for the treatment of URIs in pediatric patients. Is superior to other antibiotics in relation to bacterial eradication. Its equivalence profile related to clinical cure, clinical success and relapse risk, let to consider it as an important alternative.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Clarithromycin / adverse effects
  • Clarithromycin / therapeutic use*
  • Humans
  • Infant
  • Randomized Controlled Trials as Topic
  • Respiratory Tract Infections / drug therapy*


  • Anti-Bacterial Agents
  • Clarithromycin