A DOUBLE-BLIND, MULTICENTER COMPARATIVE-STUDY OF 2 REGIMENS OF CLINDAMYCIN HYDROCHLORIDE IN THE TREATMENT OF PATIENTS WITH ACUTE STREPTOCOCCAL TONSILLITIS PHARYNGITIS

In a double-blind, prospective, randomized, multicenter study, 164 pat ients with a clinical and bacteriologic diagnosis of acute streptococc al tonsillitis/pharyngitis were enrolled to compare the efficacy and s afety of two regimens of clindamycin. A rapid identification test of G roup A beta-hemolytic streptococci (GABHS) was used to initiate the th erapy; however, a positive tonsillar/pharyngeal culture was required a t pretreatment to determine if the patient was assessable. Another cul ture was repeated at least 2 days after the 10 days of drug therapy. F rom 164 patients enrolled (mean age, 27.7 years; range, 14 to 60 years ), 141 were assessable for efficacy; 22 patients were excluded because they did not have a positive culture at pretreatment and 1 patient di d not complete the study due to a side effect (rash). All patients wer e included in the safety analysis. Patients received either clindamyci n hydrochloride capsules 150 mg four times per day (QID) or clindamyci n hydrochloride capsules 300 mg two times per day (BID) and placebo ca psules BID for 10 days. There were no significant differences between groups in terms of demographics, medical history, and evolution of sym ptoms. The clinical efficacy rate in the two groups at day 12 was as f ollows: QID group-cured, 64 (92.8%) of 69 patients; improved, 5 (7.2%) of 69 patients; BID group-cured, 67 (93.1%) of 72 patients; improved, 5 (6.9%) of 72 patients. There were no significant differences betwee n the groups. Both regimens were well tolerated with only 1 patient in the QID group who did not complete the therapy due to a rash. The GAB HS were eradicated in 66 (96%) of 69 patients in the QID group and in 70 (97%) of 72 patients in the BID group. In conclusion, this study sh owed that clindamycin hydrochloride administered BID (300 mg every 12 hours) had a rate of clinical and microbiologic efficacy similar to th e standard clindamycin regimen (150 mg QID), and a similar safety prof ile in patients with acute streptococcal tonsillitis/pharyngitis.