As part of a clinical research program for a new antibiotic from the ketolide group - telithromycin (Ketek, Aventis) - two multicentre randomized phase III trials were conducted comparing the effectiveness of a 5-day course of telithromycin with a 10-day course of phenoxymethylpenicillin or clarithromycin for tonsillophytosis caused by hemolythotenitis Streptococcus serogroup A (BHSA).

Patients 13 years and older with acute BGSA tonsillopharyngitis were randomized to receive treatment with telithromycin at a dose of 800 mg once daily for 5 days (430 patients), phenoxymethylpenicillin at a dose of 500 mg three times a day for 10 days (197 patients) or clarithromycin at a dose of 250 mg twice a day for 10 days indoors (231 patients).

Following a bacteriological study of throat swabs obtained when patients were included in the study, 590 strains of HSSA (Streptococcus pyogenes) were isolated. In all strains isolated, susceptibility to antibiotics in vitro was determined by determining the MIC of telithromycin, clarithromycin and azithromycin. The activity of telithromycin in vitro was higher than the activity of clarithromycin and azithromycin (MPC 50/90 = 0.03 / 0.06 μg / ml vs 0.06 / 0.06 and 0.12 / 0.25 mg / ml, respectively), including BHSA strains resistant to erythromycin.

When evaluating the efficacy of the treatment after treatment on day 16-23, it was found that a satisfactory bacteriological effect was obtained in 88.3% (234/265) of patients in the telithromycin group and in 88.6% (225/254) of patients receiving comparison medicines. In general, eradication of HBSS was noted in 88.7% (235/265) of the cases treated with telithromycin and in 89.0% (226/254) when using comparator drugs. The clinical efficacy indicators for telithromycin treatment and comparison drugs, evaluated after treatment (days 16-23), were 93.6% (248/265) and 90.9% (220/242), respectively..

In general, telithromycin was well tolerated. Among the identified adverse events, possibly associated with treatment with the drug studied, the majority were mild disorders of the gastrointestinal tract.

In the two therapy groups, only a few cases of drug withdrawal due to the development of adverse events were noted.

Thus, the analysis of the combined data showed that a 5-day treatment with telithromycin at a dose of 800 mg once a day is not less effective than 10-day treatments with phenoxymethylpenicillin at a 500 mg dose three times daily or clarithromycin 250 mg twice daily indoors with tonsillopharyngitis caused by serogroup A beta-hemolytic streptococcus