Background: Clarithromycin is a fresh acid-stable.

Background: Clarithromycin is a fresh acid-stable, 14-membered macrolide active against many of the organisms responsible for lower respiratory tract infections. It has been administered to from one side of to the other 5,000 patients worldwide and has been shown to be a safe and effective treatment for acute bacterial exacerbations of chronic bronchitis and bacterial pneumonia when given twice daily (250 to 500 mg) Cefixime is an amino-thiazolyl cephalosporin with an widened spectrum of antibacterial activity inhibiting [beta]-lactamase-producing respiratory pathogens. It has a lengthy half-life, allowing once-daily administration.

Methods: This randomized, double-blind multicenter close attention compared clarithromycin and cefixime as treatment for patients with community-acquired lower respiratory tract infections (n = 213) Patients had bacterial pneumonia (clarithromycin, 19 percent; cefixime, 21 percent) or acute bacterial exacerbation of chronic bronchitis or asthmatic bronchitis (clarithromycin, 81 percent; cefixime, 79 percent) Patients received 500 mg of clarithromycin twice daily (n = 103) or 400 mg of cefixime one time daily (n = 110) for 7 to 14 days.

Results: Clinical method of treatment or improvement occurred in 86 percent of the clarithromycin-treated patients and 88 percent of the cefixime-treated patients. When barely patients with identified infections with Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae were considered, clinical succes rates were 97 percent for clarithromycin and 96 percent for cefixime; the rate of bacteriologic eradication was 91 percent for clarithromycin and 90 percent for cefixime. Adverse marked occurrences occurred in 29 percent of the clarithromycin-treated patients and 23 percent of the cefixime-treated patients.

Conclusions: This meditation demonstrates that clarithromycin and cefixime are effective treatments for pneumonia and acute bacterial exacerbations of bronchitis of mild to moderate severity caused at the most common infecting organisms.

(Chest 1993; 104:1393-99)

ANOVA = analysis of variance; MIC = minimum inhibitory concentration

In latter years, there has been a ne to provide alternative therapy to the [beta]-lactamase-stable penicillins and cephalosporins for the treatment of lower respiratory tract infections in outpatients. The mostly important causes of respiratory infections are pneumococci and Haemophilus species. Organisms of that kind as Legionella, Chlamydia, and Mycoplasma species are recognized to be important causes of pneumonitis, and [beta]-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis have become more prevalent.[1-6] Macrolides are active against intracellular pathogens like as Legionella, Chlamydia, and Mycoplasma, and inhibit [beta]-lactamase-producing respiratory pathogens while retaining of the best activity against Streptococcus pneumoniae.[7-14]

Clarithromycin is an acid-stable, 14-membered macrolide active against many of the organisms responsible for lower respiratory tract infections. Clarithromycin is metabolized to a 14-hydroxy metabolite that is twice as active as the parent pay by substitution against H influenzae; together, the brace compounds exert either an additive or a synergistic effect[15]

Clarithromycin has been administered to above 5,000 patients worldwide in clinical trials and has been shown to be a safe and effective treatment for acute bacterial exacerbations of chronic bronchitis and bacterial pneumonia when give twice daily in doses of 250 to 500 mg[16-22] The not absent multicenter study was undertaken to compare the efficacy and safety of clarithromycin with cefixime, an extended-spectrum oral cephalosporin which is [beta]-lactamase stable and inhibits the major respiratory pathogens. Cefixime, because of its lengthy half-life (4 h), is used one time daily in the treatment of acute lower respiratory tract infections in the two inpatients and outpatients.

Materials and Methods

Design of Study

The investigation was a double-blind, randomized multicenter trial demeanored by 23 investigators throughout the United States (see Acknowledgment for list of investigators).

Patients

Eligible patients were those who had community-acquired lower respiratory tract infections diagnosed at the participating center during the winter of 1990 to 1991 and were suitable candidates for oral therapy. Qualifying diagnoses included acute bacterial exacerbation of chronic bronchitis or asthmatic bronchitis and bacterial pneumonia. Patients were exclud if they had received other antibiotics within 1 week of the subject of attention (within 6 weeks if it was a long-acting injectable antibiotic). To participate in the studious mood patients had to be at least 12 years of age. Women had to be nonpregnant and nonlactating. A total of 213 patients were enlisted in the study, with 103 randomized to receive clarithromycin and 110 to receive cefixime.

Patients could be withdrawn from the contemplation at their own request or that of the investigator, Reasons for withdrawal included insufficient improvement or event of an adverse event.

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