Ioversol clinical safety summary.

The authors evaluated double-blind comparative and open-label clinical trials in 1,186 patients who received ioversol to evaluate the safety and efficacy of ioversol, a new nonionic low-osmolality contrast medium, at iodine concentrations of 32%, 24%, and 16%. The results indicate that ioversol was well tolerated in all patients and showed fewer adverse effects than conventional ionic agents. The diagnostic efficacy of ioversol was comparable to both conventional and other nonionic agents with respect to diagnostic quality. However, the improved patient tolerance may contribute to higher quality radiographs. The effects on renal function were monitored at 24, 48, 72, and 96 hours and did not reveal any clinically or statistically significant changes.

Randomized trial of ciprofloxacin compared with other antimicrobial therapy in the treatment of osteomyelitis.

Thirty adults (mean age, 52 years) were enrolled in a randomized, comparative trial of oral ciprofloxacin (750 mg twice daily) and other antimicrobial therapies. Etiologic agents included Enterobacteriaceae (18 isolates), Pseudomonas aeruginosa (16 isolates), and Staphylococcus aureus (four isolates). Seven of 14 (50 percent) ciprofloxacin-treated infections are cured at up to 13 months follow-up and three infections appear improved. Treatment failure or relapse has occurred in four patients. Sixteen patients received other antimicrobial therapy and 11 patients (65 percent) remain without infection and have healed wounds, with follow-up from one to 13 months. One patient has had a relapse, while improvement is apparent in four patients. Complications that occurred in this group included drug-related neutropenia (two patients), diarrhea (two patients), drug allergy (one patient), and catheter-related staphylococcal cellulitis (one patient). Oral ciprofloxacin therapy for chronic osteomyelitis caused by susceptible organisms appears to be as effective as other antimicrobial therapies.

Treatment of bone, joint, and soft-tissue infections with oral ciprofloxacin.

We treated 52 patients with orally administered ciprofloxacin. In this study of 34 men and 18 women who completed therapy and who could be evaluated, there were 29 patients with nonhematogenous osteomyelitis, 20 patients with skin or soft-tissue infections, and 3 patients with joint infections. During the study, 92 isolates of pathogenic facultative aerobic bacteria, including 37 members of the family Enterobacteriaceae, 30 Staphylococcus aureus isolates, and 21 Pseudomonas aeruginosa isolates, were recovered, and 88 (96%) of the isolates were found to be susceptible to ciprofloxacin. Of the 29 patients with osteomyelitis, 14 have not experienced relapse after a follow-up of at least 1 year. Overall, 61% of infections were resolved, as judged by both clinical and microbiological criteria, during therapy. One patient developed Streptococcus salivarius sepsis during ciprofloxacin therapy, and one patient developed a rash which required discontinuation of ciprofloxacin. Otherwise, there were no serious reactions or complications.

Comparison trial of clindamycin with aztreonam or gentamicin in the treatment of postpartum endometritis.

Sixty-two patients who had postpartum endometritis were treated with clindamycin in combination with either aztreonam or the aminoglycoside gentamicin. Currently, the combination of clindamycin and an aminoglycoside constitutes a treatment of choice for this condition. Our results suggest that aztreonam can be substituted for an aminoglycoside in the treatment of postpartum endometritis with similar clinical outcomes.

Cefoperazone-sulbactam combination in the treatment of urinary tract infections: efficacy, safety, and effects on coagulation.

Seventy hospitalized patients with upper urinary tract infections were treated with cefoperazone (2 gm) and sulbactam (1 gm) every 12 hours for three or more days. All but six patients also received vitamin K. Forty of the 70 patients (57%) were cured of infection at one week after treatment, 13 relapsed, 11 had reinfections, and six were lost to follow-up. There were no treatment failures. Escherichia coli was the predominant pathogen (62% of isolates). Overall there was 15% resistance to cefoperazone and all resistant isolates were susceptible to the combination of agents. Synergy was demonstrated in 26% of isolates. One uroseptic patient who had an organism resistant to both study agents, but susceptible to the combination, was cured. Two of six patients who did not receive vitamin K demonstrated abnormal coagulation patterns and one had an associated major bleeding complication. Although 12 of 64 (19%) patients who received vitamin K had at least one coagulation abnormality, there were no significant bleeding complications in this group.

Randomized study of single-dose, three-day, and seven-day treatment of cystitis in women.

We evaluated the following five treatment regimens for acute cystitis in nonpregnant women: cefadroxil, 1,000 mg single-dose; cefadroxil, 500 mg twice a day for three days; cefadroxil, 500 mg twice a day for seven days; trimethoprim-sulfamethoxazole (TMP-SMZ), 320-1,600 mg single-dose, and TMP-SMZ, 160-800 mg twice a day for three days. At four weeks after the end of treatment, 25%, 58%, 70%, 65%, and 88% of patients, respectively, remained cured of infection. The results indicated that three-day treatment (1) might improve cure rates (over single-dose), (2) would reduce incidence of relapse (vs. single-dose), and (3) may be as curative as seven-day treatment. The results of the antibody-coated bacteria test did not predict treatment failure or relapse.