ly-163892 and Pharyngitis

A double blind, randomized clinical trial compared loracarbef (LY163892) with penicillin VK. Two hundred thirty-three pediatric patients (less than or equal to 12 years) with a diagnosis of pharyngitis or tonsillitis resulting from Group A beta-hemolytic streptococci were randomized to treatment. Patients in the loracarbef group (n = 120) received loracarbef as a 15-mg/kg/day oral suspension or 200-mg capsule taken twice daily for 10 days. Patients in the penicillin group (n = 113) received penicillin VK as a 20-mg/kg/day oral suspension or 250-mg capsule taken four times daily for 10 days. Successful clinical responses were demonstrated in 101 of the 104 (97.1%) evaluable patients treated with loracarbef compared with 83 of 88 (94.3%) of evaluable patients treated with penicillin. The clinical relapse rate for the loracarbef group was 2.9% vs. 5.7% for the penicillin group. Bacteriologic response data approximated the clinical response data, as eradication of Group A beta-hemolytic streptococci was found in 86.5 and 81.8% of the loracarbef group and the penicillin group, respectively. No statistically significant difference in the incidence of treatment-emergent adverse reactions was noted between the two groups. The results indicate that loracarbef taken twice daily was comparable in safety and efficacy to penicillin VK taken four times daily in the treatment of Group A beta-hemolytic Streptococcus-associated pharyngitis and tonsillitis in children.

Topics: Cephalosporins; Child; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Male; Penicillin V; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

Loracarbef, a member of the carbacephem class of beta-lactam antibiotics, is a potent anti-bacterial agent. In a double-blind, randomized clinical trial to assess the efficacy and safety of loracarbef in the treatment of streptococcal pharyngitis and tonsillitis, 107 adult patients were treated with loracarbef (200 mg capsules twice a day or 15 mg/kg/day suspension) and 111 patients were treated with penicillin VK (250 mg capsules four times a day or 20 mg/kg/day suspension) for 10 days. In the loracarbef treatment group, 96.6% of the evaluable patients had a favorable clinical response 3-5 days after therapy, a result that compared favorably with the 93.9% response rate achieved in the penicillin group. The clinical failure/relapse rates were 3.4% for loracarbef-treated patients and 6.1% for patients receiving penicillin. Bacteriologic response data approximated the clinical results, with a successful response in 89.9% of the loracarbef-treated patients and 91.5% of the penicillin recipients. Two (1.9%) loracarbef-treated patients with rash and one (0.9%) penicillin-treated patient with diarrhea discontinued the study early because of these adverse events. The incidence of adverse events was comparable in the two treatment groups except for increased cough, which was reported by 3.7% of the loracarbef-treated patients and none of the penicillin recipients. These data support the conclusion that loracarbef is comparable to penicillin VK in the treatment of streptococcal pharyngitis and tonsillitis in adults.

Topics: Adult; Cephalosporins; Cough; Diarrhea; Double-Blind Method; Headache; Humans; North America; Penicillin V; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes; Tonsillitis

The in vitro activity of loracarbef, penicillin V, cefaclor and cefadroxil against log and stationary phase cultures of group A streptococci was compared. MICs and MBCs were determined with the broth dilution method and by a modified agar plate dilution technique where the beta-lactams were inactivated after the MICs were determined allowing inhibited but not killed organisms to grow on further incubation. The MICs of loracarbef and the two cephalosporins were 16-32 times higher than those of penicillin V. In plate dilution the MBC/MIC ratios of all agents were < or = 2 for log phase cultures. With stationary phase cultures, especially in the broth dilution test, the MBC/MIC ratios of loracarbef and the two cephalosporins were > or = 32 for a large number of strains. The phenotype response of stationary phase cultures to beta-lactam antibiotics may not only be related to the physiological status of the streptococci, to the culture conditions and to the beta-lactam under test. The present investigation indicated that the phenotypic response was also an intrinsic property of certain strains.

Topics: Anti-Bacterial Agents; Cefaclor; Cefadroxil; Cephalosporins; Humans; In Vitro Techniques; Microbial Sensitivity Tests; Penicillin V; Pharyngitis; Streptococcal Infections; Streptococcus pyogenes