Oral ciprofloxacin vs parenteral cefotaxime in the treatment of difficult skin and skin structure infections. A multicenter trial.

A prospective, randomized, double-blind, multicenter study was conducted of hospitalized patients to compare the efficacy and safety of oral ciprofloxacin (dosage, 750 mg every 12 hours) with intravenous cefotaxime (dosage, 2.0 g every 8 hours) as monotherapy for difficult skin and skin structure infections requiring hospitalization. Five hundred seventy patients were assessed for an analysis of safety and 461 patients were assessed for an analysis of efficacy. The most common infections were infected ulcers and abscesses. At the end of therapy, there was a higher incidence of recurrent or persistent organisms in the cefotaxime group compared with ciprofloxacin. Adverse reactions related to either therapy were rare. By pathogens, there were no differences in activity, except the higher rate of recurrent or persistent Pseudomonas aeruginosa infection in the cefotaxime group. By diagnosis, the two drugs had comparable efficacy, except for the higher incidence of bacteriologic failure in patients with polymicrobial infected ulcers in the cefotaxime group. Larger studies are needed to evaluate emergence of resistance to ciprofloxacin. Oral ciprofloxacin therapy is as safe and effective as parenteral cefotaxime in the treatment of difficult infections of the skin and skin structure, and affords the prospect of early discharge from the hospital and significant cost savings.

Treatment of acute bacterial diarrhea: a multicenter international trial comparing placebo with fleroxacin given as a single dose or once daily for 3 days.

This study was designed to test the efficacy of 400 mg fleroxacin given orally as a single dose or once daily for 3 days against acute bacterial diarrhea. A group of 508 adults with acute diarrhea were entered into a randomized, double-blind, placebo-controlled, multicenter trial. Patients were examined and asked about numbers of liquid stools daily for 3 days and at 5 days after start of treatment. Repeat stool samples were obtained for culture on days 3 and 5 after start of treatment. A total of 332 patients showed stool cultures positive for bacterial pathogens sensitive to fleroxacin and completed their treatments. Patients treated with fleroxacin, both single-dose and 3-day regimens, showed faster clinical improvement than did placebo-treated patients, as shown by earlier cessation of diarrhea (p < 0.001) and reduction in mean number of loose stools per day on days 2, 3, and 5 after start of therapy (p < 0.05). Bacteriologic efficacy was demonstrated by negative stool cultures for initial pathogens on days 3 and 5 after start of therapy in 94% of patients treated with single doses of fleroxacin and in 93% of patients treated with three doses of fleroxacin as compared with 57% of patients treated with placebo (p < 0.001). Patients with cholera, shigellosis, and infections due to Vibrio parahaemolyticus showed both clinical and bacteriologic responses to fleroxacin treatment, whereas patients with salmonellosis showed only bacteriologic responses. The good overall clinical and bacteriologic responses of most patients with acute bacterial diarrhea of fleroxacin indicate that this convenient single-dose therapy should be advantageous for empiric treatment of certain diarrheal illnesses.

Short-term study of quazepam 15 milligrams in the treatment of insomnia.

The hypnotic efficacy and safety of quazepam 15 mg was compared with placebo in thirty-six out-patients with insomnia. The study was double-blind, with two comparable groups of patients established by random allocation. Following a placebo baseline period, patients took placebo or quazepam for 5 consecutive nights and completed sleep questionnaires the next day. Quazepam was rated better than placebo in terms of sleep quality, sleep induction time, total sleep time, and early morning awakenings. Quazepam treatment was rated as good or excellent by the physician and the patients who received it almost three times more often was placebo. Quazepam was proved to be safe, with no reports of unexpected or serious adverse experiences.

A comparative study of the efficacy and safety of azlocillin and gentamicin in the treatment of serious infections.

Azlocillin, a new semisynthetic ureidopenicillin, has increased in-vitro activity against Pseudomonas aeruginosa and good activity against other Gram-negative organisms. In a comparative clinical study, azlocillin was administered intravenously at 18 g/day to 24 patients and gentamicin intramuscularly at 3 to 5 mg/kg/day to 25 patients, most of whom had infections of the skin and skin structure, intra-abdominal cavity, or lower respiratory tract. Gram-negative organisms, usually Ps. aeruginosa or Escherichia coli, and Staphylococcus aureus, were isolated most frequently. At the end of therapy, 18/24 (75%) of the patients with one infection site had an excellent clinical response after azlocillin, as compared with 7/20 (35%) after gentamicin (P = 0.014). The overall response to treatment was cure in 17/24 (70.8%) of the azlocillin patients and 9/24 (37.5%) of the gentamicin patients (P = 0.042). Bacteriological response was in the azlocillin group 28/33 or 84.8% as compared to the gentamicin group 38/51 or 74.5%.