Effects of cefixime or co-amoxiclav treatment on nasopharyngeal carriage of Streptococcus pneumoniae and Haemophilus influenzae in children with acute otitis media.

A multicentre, open-label, randomized study was performed in 501 out-patients with acute otitis media, aged 6-36 months, to study the impact of treatment with either cefixime suspension 8 mg/kg/day bd or co-amoxiclav suspension 80 mg/kg/day tds for 10 days on nasopharyngeal carriage of Streptococcus pneumoniae and Haemophilus influenzae. Of 426 patients with nasopharyngeal cultures at entry to the trial, end of treatment and at follow-up visit (35 days after inclusion), significant changes in carriage of S. pneumoniae were observed. The proportion of penicillin-resistant S. pneumoniae was higher in the samples taken at the end of treatment and follow-up than in those taken at inclusion, while the total number of children with this microorganism was lower. The difference at the end of treatment was greater with co-amoxiclav than with cefixime. For H. influenzae the resistance rate remained steady while the number of children with this microorganism decreased. At follow-up there was no significant difference between the two groups in terms of nasopharyngeal positive culture for S. pneumoniae or H. influenzae. Despite these differences, successful clinical responses were similar at the end of treatment and at follow-up.

Analysis of oral antibiotic treatment that failed to prevent the development of Haemophilus influenzae meningitis: consequences on mortality.

One hundred and four children suffering from Haemophilus influenzae meningitis were studied in a multi-centre study in France between October 1991 and June 1993. The clinical and bacteriological findings were similar to those usually found in this condition. Fifty three per cent of the H. influenzae strains cultured produced beta-lactamase and 98% were of type b. Forty-six children who had been prescribed oral antibiotics before hospitalisation were analysed in this study. This analysis took into account the nature of the antibiotic and whether it was prescribed as the treatment of first or second intention. Treatment failures, defined according to pre-established criteria, were found to be independent of whether or not the incriminated strain was beta-lactamase producing and whether or not it was sensitive in vitro to the antibiotic prescribed. None of the 46 children who had received pre-hospital oral antibiotics died while three of the 58 who had received pre-hospital oral antibiotics died. However, it is difficult to establish in our study a clear relationship between the reduction of mortality and previous oral antibiotic treatment in bacteriologically proven cases of H. influenzae meningitis.

Long-term outcome and quality of life of patients requiring multidisciplinary intensive care unit admission after cardiac operations.

Patients with organ failure or severe infection after cardiac operations may require prolonged stays in the intensive care unit. This study examined long-term mortality and determined quality of life for surviving patients in this group. This observational cohort study was conducted at Bichat Hospital, Paris, an academic tertiary care center. The study group consisted of 116 consecutive patients who underwent cardiac operations and were transferred to the multidisciplinary intensive care unit between January 1986 and December 1987. Patients referred for mediastinitis were automatically excluded. Respiratory failure (88.8%) and hemodynamic instability (81.9%) were the main causes of transfer; an infection was present in 23.3% of patients at entry into the intensive care unit. Twenty-seven patients (23.3%) died in the intensive care unit. Presurgical New York Heart Association functional class, postoperative bacteremia before admission to the intensive care unit, and severity of illness on admission to the intensive care unit were independent predictors of death in the intensive care unit. After an average follow-up of 81 months (range 70 to 93 months), 69% of the patients alive at transfer from the intensive care unit were still alive. Preoperative New York Heart Association functional class was the only long-term independent prognostic factor. Quality of life, as evaluated by the Nottingham Health Profile, was good for more than 70% of the survivors and was not influenced by any recorded variables, with the exception of age.

Roxithromycin versus penicillin in the treatment of erysipelas in adults: a comparative study.

A prospective, randomized, multicentre trial was conducted to evaluate the efficacy and safety of roxithromycin (150 mg b.i.d. orally) and penicillin (2.5 MU x 8 daily intravenously, then 6 MU daily orally) in the treatment of hospitalized adult patients with erysipelas. Seventy-two patients entered the study. Thirty-one patients in the roxithromycin group and 38 patients in the penicillin group completed the trial. The overall efficacy rates (cure without additional antibiotics) were 84% (26/31) in the roxithromycin group and 76% (29/38) in the penicillin group (P = 0.43). No side-effects were observed in the roxithromycin-treated patients whereas rashes occurred in two cases in the penicillin group, leading to exclusion from the study. Oral roxithromycin can thus be considered an effective and well-tolerated treatment for erysipelas in adult hospitalized patients.

Penetration of roxithromycin into gingival tissue.

Roxithromycin is a new macrolide with an antibacterial spectrum similar to that of erythromycin. Absorption is rapid and complete, resulting in high serum levels and a long half-life. Tissue distribution is extensive and sustained, as shown by the high concentrations measured in the lung, prostate, ovaries, liver, kidney, and skin. In this study, we measured the penetration of roxithromycin into gingival tissue at steady state in 30 patients treated orally with 150 mg every 12 hr for 5 days. Tissue specimens were sampled at 2, 4, 6, 8, or 12 hr (n = 6 each time) after dose 10, and blood samples were taken simultaneously. Serum and tissue concentrations of roxithromycin were measured by high-performance liquid chromatography. The peak serum level, reached 4 hr after dosing, was 6.60 +/- 1.15 micrograms/ml. The peak tissue level was 4.63 +/- 1.84 micrograms/g and was reached after 8 hr. From 4 to 10 hr after dosing, tissue concentrations were greater than 2 micrograms/g, that is, higher than the MIC90 of roxithromycin against most oral pathogens. These data support the use of roxithromycin in the treatment of oral infections.

Comparison of two oral antibiotics, roxithromycin and amoxicillin plus clavulanic acid, in lower respiratory tract infections.

In a randomized, multicenter, open-label study, 490 ambulatory adult patients with lower respiratory tract infection (LRTI) were randomized to roxithromycin (ROX) 150 mg b.i.d. orally (n = 244) or amoxicillin plus clavulanic acid (AMX + CA) as 500 mg AMX + 125 mg CA t.i.d orally (n = 24). Clinical results were analyzed in 477 patients with acute bronchitis (79%), chronic bronchitis (CB) (14%), and pneumonia (7%). There were significantly more patients with underlying disease (cardiovascular diseases, p = 0.045; and alcoholism, (p less than 0.001), and more patients over the age of 65 years (p = 0.045) in the ROX group. Overall clinical efficacy was similar in both groups: 88% (206:235) in the ROX group and 85% (205:242) in the AMX + CA group. Side effects were reported in 67 cases (28%) in the AMX + CA group and in 21 cases (9%) in the ROX group (p less than 0.0001), causing withdrawal in 21 and three cases, respectively (p less than 0.001). Thus, despite being administered to a significantly older and more ill group of patients with LRTI, roxithromycin was as effective as amoxicillin plus clavulanic acid and better tolerated.

Multicenter double-blind study of the efficacy and tolerance of roxithromycin versus erythromycin ethylsuccinate in acute orodental infection in adults. Odontogenic Infections Study Group.

A total of 194 patients with orodental infection were randomized either to roxithromycin 150 mg twice daily plus placebo or to erythromycin 1 g twice daily plus placebo for a mean duration of 8 days. The infections consisted of cellulitis, pericoronitis, and adenopathy, or any two in combination. In the 176 cases in which efficacy was evaluable, outcome was satisfactory in 94% and 91% of cases treated with roxithromycin and erythromycin, respectively (p = 0.45). Patients were evenly distributed with respect to demographic characteristics, diagnosis, and concomitant treatment. Surgery was performed in 63%, primarily for abscess formation in cellulitis (p less than 0.001); 18% of patients with an abscess did not undergo surgery. The success rate was identical irrespective of whether surgery was performed, including in those with an abscess. Tolerance was evaluated in 1986 patients. Unwanted effects, elicited by direct questioning, were reported in approximately 20% of cases per group (19% for roxithromycin and 21% for erythromycin). They consisted of mild gastrointestinal upsets which caused treatment to be withdrawn in eight cases (four per group). Thus, roxithromycin and erythromycin twice daily for orodental infection are similar in both efficacy and tolerance.