ABSTRACT
The efficacy and safety of a 5-day regimen of 800 mg telithromycin once daily was compared with a standard 10-day regimen of 500 mg cefuroxime axetil twice daily in a multicentre, randomized, double-blind, parallel-group trial involving 376 patients with acute exacerbations of chronic bronchitis (AECB). In clinically evaluable patients (n = 282), post-therapy clinical cure rates were 86.4% with telithromycin and 83.1% with cefuroxime axetil. In bacteriologically evaluable patients (n = 53), eradication or presumed eradication of the pathogen was achieved in 76.0% and 78.6% of telithromycin and cefuroxime axetil patients, respectively. Adverse events were mostly mild; the most common were diarrhoea (12.8% versus 11.8%) and nausea (8.9% versus 3.2%) in telithromycin and cefuroxime axetil patients, respectively. The 5-day regimen of 800 mg telithromycin once daily was similar in efficacy and equally well tolerated as a 10-day regimen of 500 mg cefuroxime axetil twice daily in adults with AECB.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Bronchitis, Chronic/drug therapy , Cefuroxime/analogs & derivatives , Cefuroxime/administration & dosage , Ketolides , Macrolides/administration & dosage , Administration, Oral , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/adverse effects , Cefuroxime/adverse effects , Female , Humans , Macrolides/adverse effects , Male , Middle Aged , Prognosis , Treatment OutcomeABSTRACT
This study assessed the safety and efficacy of filgrastim (r-metHuG-CSF [recombinant human methionine granulocyte colony-stimulating factor]), when combined with intravenous (IV) antibiotics, in the treatment of hospitalized adult patients with multilobar community-acquired pneumonia (CAP). Four hundred eighty patients were randomized to receive placebo (n=243) or filgrastim 300 microg/day (n=237), in addition to standard therapy. Treatment with study drug was continued for 10 days, until the peak white blood cell (WBC) count reached 75x109/L, until discharge from the hospital, until death, or until IV antibiotics were discontinued. Study-related observations continued through day 29. Filgrastim increased WBC counts (baseline median, 13.3x109/L; median peak, 43. 8x109/L). The 2 treatment groups were not statistically different with respect to the study end points; however, there was a trend toward reduction of mortality in patients with pneumococcal bacteremia. Although further studies will be required to validate this observation, filgrastim was safe and well tolerated when administered to patients with multilobar CAP.
