[Comparative trial of the clinical efficacy and tolerance of cefatrizine (Cefaperos) and cefpodoxime proxetil (Orelox) in superinfections of chronic obstructive bronchopneumopathies in adults in urban practice]. / Essai comparatif de l'efficacité et de la tolérance clinique entre la céfatrizine (Cefaperos) et le cefpodoxime proxétil (Orelox) dans les surinfections des bronchopneumopathies chroniques obstructives de l'adulte en médecine de ville.

In order to compare the clinical efficacy and safety of cefatrizine (Cefaperos) and cefpodoxime proxetil (Orelox) in the treatment of secondarily infected chronic obstructive pulmonary disease (COPD) in adults, a multicentre, randomized, open study was conducted by 60 general practitioners in two parallel groups of patient suffering from COPD complicated by an acute episode of superinfection (Anthoniesen stages 2 and 3). After verification of the eligibility criteria, written consent and randomization, the patients received, for 10 days, either cefatrizine at the dose of 1 g/day or cefpodoxime proxetil at the dose of 400 mg/day. A self-assessment form was given to the patient. A telephone visit was planned for D3. The final visit on D11 +/- 1 evaluated clinical efficacy (success or failure) and safety. The study population was composed of 250 patients with a mean age of 59.9 +/- 15.9 years (sex ratio M/F = 1.5). The principal etiology of COPD was chronic bronchitis in 67.5% of patients, longstanding asthma in 24.5% and emphysema in 6.8%. The mean history of the disease was 13.0 +/- 10.8 years. The Anthoniesen score was equal to 2 in 73.6% of patients, 3 in 8.8% of patients and 1 in 17.6% of patients. No significant difference concerning these criteria was observed between the two study groups. The clinical success rate was equivalent in the two groups. The time to regression of clinical signs tended to be shorter, up until the sixth day (mainly between D4 and D6) for patients treated with cefatrizine (p = 0.09; NS). The clinical safety was considered to be good and was comparable in the two study groups. This study concluded on the equivalent clinical efficacy of cefatrizine and cefpodoxime proxetil in the treatment of superinfections of COPD in general practice (97.5% and 99%, respectively), with a satisfactory and comparable safety, but with a much lower cost of treatment for cefatrizine. This conclusion is particularly important in the context of opposable medical references, as, although the treatment of superinfections of COPD by second and third generation cephalosporins is frequently proposed, the prescription of a less expensive cephalosporin appears to be more relevant.

A double-blind clinical comparison of two dosage schedules of cefatrizine in children.

A double-blind, randomized clinical trial was carried out to compare the effectiveness of twice daily versus once daily administration of the cephalosporin, cefatrizine, in paediatric outpatients with bacterial infection of the respiratory tract. Thirty children were studied, aged 7 years 2 months (range, 4-12 years). They were given 75 mg/kg.day cefatrizine either once daily or twice daily at 12 h intervals for 8 days. Fever, clinical symptoms, bacterial eradication and overall tolerance were evaluated. No significant differences were observed between once daily or twice daily administration. This is in agreement with other studies carried out on adults. It is concluded that cefatrizine may be given to paediatric out-patients for the treatment of bacterial infection of the respiratory tract only once daily with good clinical and overall results.

Controlled multicenter clinical comparison between two cefatrizine administration schedules: a contribution to improvement of compliance in clinical nonhospital use of antibiotics.

Eight Italian clinical centers carried out a controlled double-blind/double-dummy evaluation of the effectiveness of two different administration schedules of cefatrizine, an orally active cephalosporin. The first schedule provided for once-a-day administration of 1.5 gm of the drug, and the second one for twice-a-day administration of 0.75 gm. The trial included 160 patients affected by bacterial diseases of the respiratory apparatus. The two drug administration schedules were found to be equivalent in clinical and bacteriological results and in tolerability.