Evaluation of Antimicrobial Treatments in Children with Acute Otitis Media in Spain: A Pharmacokinetic-Pharmacodynamic (PK/PD) Approach

• Published in: Journal of chemotherapy (Florence) 2005-12, Vol.17 (6), p.628-635
• Main Authors: Beobide, I., Canut, A., Gascón, A.R., Isla, A., García-Rey, C., De La Maza, I., Labora, A., Pedraz, J.L.
• Format: Article
• Language: English
• Subjects: Acute Disease; Acute otitis media; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - pharmacokinetics; Anti-Bacterial Agents - pharmacology; antibiotics; Biological Availability; Child; Child, Preschool; children; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Combinations; Drug Resistance, Bacterial; Haemophilus Infections - drug therapy; Haemophilus influenzae - drug effects; Haemophilus influenzae - isolation & purification; Humans; Infant; Metabolic Clearance Rate; Microbial Sensitivity Tests; Otitis Media - drug therapy; pharmacodynamics; pharmacokinetics; Pneumococcal Infections - drug therapy; Spain; Streptococcus pneumoniae - drug effects; Streptococcus pneumoniae - isolation & purification
• ISSN: 1120-009X; 1973-9478
• DOI: 10.1179/joc.2005.17.6.628

Pharmacokinetic/pharmacodynamic (PK/PD) principles are priceless tools for evaluating the effectiveness of different antimicrobial treatments for different infections. However, very few studies deal with pediatric dosages and take into account the unbound drug serum levels. Our study is focused on the most frequent antibiotic dosing schedules used in Spain for the treatment of acute otitis media (AOM) in children, where high rates of penicillin and macrolide resistance exist among pneumococcal isolates. Pharmacokinetic parameters of antibiotics in children where obtained from the literature. The minimum inhibitory concentrations (MIC 90 ) of antibiotics for pediatric strains of Streptococcus pneumoniae and Haemophilus influenzae were obtained from the SAUCE 2 project. Only ceftriaxone (50 mg/kg single intramuscular dose) and high doses of co-amoxiclav (27-33 mg/kg q8h) provided adequate efficacy indexes (t ss (%) >MIC ) for both S. pneumoniae and H. influenzae in AOM in children. These results are consistent with MEF (medium ear fluid) levels obtained from the literature. Our results confirm the utility of serum unbound levels to predict efficacy of antibiotics in children with AOM.