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Title: ECCMID: Ketek (Telithromycin) Effective In Penicillin/Macrolide-Resistant Respiratory Tract Infections
URL: http://www.pslgroup.com/dg/1F705A.htm
Doctor's Guide
April 4, 2001


By Jill Stein
Special to DG News


ISTANBUL, TURKEY -- April 4, 2001 -- The investigational agent Ketek (telithromycin) has significant clinical and bacteriological efficacy in patients with respiratory tract infections (RTIs), including those caused by Streptococcus (S.) pneumoniae strains resistant to penicillin and/or macrolides, investigators reported at the 11th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

Telithromycin is the first in a new family of antibiotics called ketolides that have recently been developed for the treatment of community-acquired RTIs and were specifically designed to overcome antimicrobial resistance in S. pneumoniae.

Dr. Manickam Rangaraju, with Aventis Pharma in Romainville, France, presented data from a study that compared the efficacy of telithromycin, 800 mg once daily, with several antimicrobials given for five days or seven to ten days in patients with penicillin- or macrolide-resistant pneumococcal RTIs. Comparator antimicrobials included clarithromycin 250 mg or 500 mg twice daily; trovofloxacin, 200 mg once daily; amoxicillin 1,000 mg three times daily; amoxicillin-clavulanic acid, 500/125 mg three times daily; cefuroxime/axetil 500 mg twice daily; and penicillin VK, 500 mg three times daily.

Of 371 telithromycin-treated patients with S. pneumoniae as their sole pathogen or part of a mixed infection, 89 (23.9 percent) had strains with reduced susceptibility to penicillin and/or erythromycin. Of 86 patients treated with comparator drugs who had S. pneumoniae as their sole pathogen or part of a mixed infection, 13 (15.1 percent) had strains that were resistant. Most of the resistant S. pneumoniae strains in both treatment groups were isolated from patients with community-acquired pneumonia.

Overall, 67 (91.8 percent) of 73 telithromycin-treated patients were clinically cured of their infection when analyzed at their test-of-cure visit seven to eleven days after the completion of their treatment, Dr. Rangaraju reported. By contrast, clinical cure was documented in only seven (70 percent) of ten patients treated with comparator drugs.

Similar results were observed in the intent-to-treat analysis.

Bacteriological eradication rates among these patients were also higher following telithromycin than comparator treatments ( 91.8 percent versus 80 percent for the two groups, respectively). The difference between the two groups was even more pronounced in the intent-to-treat analysis (92.7 percent versus 69.2 percent for the two groups respectively).

Overall, the results suggest that telithromycin represents an effective and reliable option for the empirical treatment of community-acquired RTIs, Dr. Rangaraju commented.

The global spread of resistance among respiratory pathogens presents a serious threat to public health, he continued. Recent results from a prospective, international study demonstrated overall resistance among 814 isolates of S. pneumoniae analysed to date of 33 percent for penicillin and greater than 50 percent for the macrolides. Virtually all isolates of S. pneumoniae were inhibited by 1 mg/L or less of telithromycin, irrespective of penicillin, macrolide, or multiple resistance.

Researchers from Aventis Pharma in Bridgewater, US, also participated in the study.

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