Clinical and pharmacological evaluation of a modified cefotaxime bid regimen versus traditional tid in pediatric lower respiratory tract infections.

It is generally accepted that the treatment of community-acquired pneumonia, either in adults or in pediatric patients, is mainly empirical. Thus, the treatment selection must fulfill both the epidemiological requirements, according to the most frequently described pathogens, and the pharmacological criteria to ensure adequate and prolonged drug concentrations at the infection site, to reach clinical efficacy. Cefotaxime has proven to be effective in this indication when traditionally administered three times daily and, more recently, twice daily, as a result of a re-evaluation of its pharmacokinetic/pharmacodynamic features. To gain further evidence using this updated dosing schedule, 258 pediatric patients with lower respiratory tract infections were treated with cefotaxime 100 mg/kg/day, administered as a twice daily or three times daily regimen. In the cefotaxime 50 mg/kg twice-daily group (n = 130), a complete resolution of clinical signs and symptoms were observed in 88.5% of patients. Similarly, in the cefotaxime 33.3 mg/kg group (n = 128), 93.6% of patients had a complete resolution of clinical signs and symptoms. Both drug schedules were well tolerated. Pharmacokinetic parameters determined for the two cefotaxime dosing schedules showed comparability. The serum half-life of desacetylcefotaxime was marginally longer than for cefotaxime in both dosage groups (1.64 and 1.36 h for desacetylcefotaxime versus 1.2 and 0.85 h for cefotaxime after 50 mg/kg or 33.3 mg/kg doses, respectively). Results from this study support the use of twice-daily cefotaxime administration for the treatment of lower respiratory tract infections in pediatric patients.

Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood.

The efficacy and safety of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl)carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) were rated in a child population with a remote history of recurrent respiratory infections (RRI). This randomized double-blind multicenter clinical trial versus placebo, stratified by age groups, involved 748 children recruited in 69 Medical Centres. The trial consisted of a 60-day treatment period and a 90-day follow-up. At the end of the treatment period the pidotimod group showed a significant decrease in the number of RRI episodes and associated symptoms vs control group. As a consequence, there was a significant decrease in the number of days of absence from kindergarten or school and in the consumption of antibiotics and symptomatic drugs. Safety was good. The effect of the drug persisted after its withdrawal throughout the whole 90-day follow-up period. During this period there was a significantly lower RRI incidence rate in the pidotimod group than in the placebo group (p < 0.01). Because of its efficacy and safety, pidotimod may be rated as an excellent drug in the RRI management in children.