As a special drug use investigation, we monitored and assessed trends in antibacterial activity of clavulanic acid/amoxicillin (1:14) (hereafter, “CVA/AMPC (1:14)”) and other antimicrobial agents for clinical isolates from pediatric patients with otitis media or respiratory, skin, and urinary tract infections.

Against Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis isolated and identifies form otorrhea, epipharynx and rhinorrhea of pediatric patients with otitis media, the MIC_90s of CVA/AMPC (1:14) in five years between 2006-2010 were 1𝜇g/mL for S. pneumoniae and 8𝜇g/mL for H. influenzae and 0.25-0.5𝜇g/mL for M. catarrhalis. The changes of MIC_90s of CVA/AMPC (1:14) for penicillin-resistant S. pneumoniae (PRSP) and 𝛽-lactamase non-producing H. influenzae were two times, and no decrease in drug susceptibility was found in the period of the present investigation. In addition, the MIC changes of other antimicrobial agents for these three organisms were approximately two to four times as well.

Against organisms isolated and identified from pus, sputum, pharynx, skin and urine of pediatric patients with respiratory, skin, and urinary tract infections, the MIC_90s of CVA/AMPC (1:14) in four years between 2008-2011 were 1𝜇g/mL for S. pneumoniae, ≤0.06𝜇g/mL for penicillin susceptible S. pneumoniae (PSSP) without any change, 0.5-1𝜇g/mL for penicillin intermediate resistant S. pneumoniae (PISP) with a twofold change and 1𝜇g/mL for PRSP with no change. The MIC_90s of CVA/AMPC (1:14) were 2-8𝜇g/mL for S. aureus with a fourfold change, 2𝜇g/mL for methicillin-sensitive S. aureus without any change, 4-8𝜇g/mL for H. influenzae with a twofold change. Against 𝛽-lactamase non-producing H. influenzae, MIC_90s of CVA/AMPC (1:14) were 1𝜇g/mL for 𝛽-lactamase negative ampicillin susceptible (BLNAS), 8𝜇g/mL for 𝛽-lactamase negative ampicillin resistant (BLNAR), showing no change. Neither Streptococcus pyogenes or Klebsiella pneumoniae demonstrated any change and M. catarrhalis and Escherichia coli showed twofold changes of MIC_90s of CVA/AMPC (1:14).

In the present investigation conducted to monitor annual changes in antibacterial activity intended for pediatric patients with otitis media or other infections, there was no significant change in antibacterial activity of CVA/AMPC (1:14).

Severely ill patients are frequently at risk of developing fungal infection. Itraconazole (ITCZ), a triazole antifungal agent, is used for the treatment of candidiasis, aspergillosis, cryptococcosis. Correlation of pharmacokinetic and pharmacodynamic (PK-PD) parameters with the in vivo bactericidal action of antimicrobial agents has progressed markedly in recent years. However, the optimal dosage of antifungal agents based on PK-PD properties has not been clearly established. In this study, we performed a population pharmacokinetic analysis of ITCZ after infusion or oral administration of ITCZ in Japanese 51 patients with fungal infections. The population pharmacokinetic analysis was performed using NONMEM software. The population mean clearance (CL; liter/h) was estimated as 5.15-0.0673×(Age-62) L/h, the population mean volume of distribution (V; liter) was determined as 878L and the bioavailability (F) was determined as 0.665.