In this multicenter.

In this multicenter, observer-blinded subject of attention 301 patients with signs and symptoms of acute bacterial exacerbation of COPD were randomized (2:1) to receive either cefpodoxime proxetil (200 mg bid) or cefaclor (250 mg tid) for 10 days. Clinical and microbiologic evaluations were performed before treatment, during therapy cogitation days 3 to 5), at the cessation of therapy (3 to 7 days posttreatment), and at long-term follow-up (4 weeks posttreatment). The in the greatest degree common pretreatment isolates were Haemophilus influenzae, Haemophilus parainfluenzae, and Streptococcus pneumoniae. Significantly (p <0001) more bacterial isolates were susceptible in vitro to cefpodoxime (233 of 256 91 percent) than to cefaclor (215 of 255 84 percent) There were no statistically significant differences between the brace drug regimens in eradication of the initial pathogen (cefpodoxime, 116 of 128 91 percent; cefaclor, 59 of 64 92 percent) or end-of-therapy clinical answer (cure + improved; cefpodoxime, 99 of 100 99 percent; cefaclor, 45 of 49 92 percent) rates for evaluable patients. the couple drug treatments were well-tolerated, with a similar incidence of drug-related adverse terminations (cefpodoxime 11 percent, cefaclor 12 percent) Cefpodoxime (bid) was as safe and effective as cefaclor (tid) in the treatment of acute exacerbation of COPD The les attend much [i]or[/i] regularly dosing regimen of cefpodoxime may improve patient compliance compared to those antibiotics that require three or four daily doses.

(Chest 1993; 104:1387-92) MIC = minimum inhibitory concentration

Chronic obstructive pulmonary disease is a general word for respiratory disorders, including asthma, emphysema, and chronic bronchitis, that decrease air be derived Acute bacterial infections of the respiratory tree in patients with COPD are often met with and associated with significant morbidity and mortality, frequently due to respiratory failure.[1,2]

Since pathogenic organisms may not be isolated from up to 50 percent of feculent sputum samples from patients with acute exacerbation of COPD antibiotic therapy is oftentimes based on likely pathogens rather than the isolation of any specific causative agent(s).[3] Pathogens commonly associated with acute exacerbation of COPD have demonstrated increasing resistance to traditional therapies for respiratory infections. Therapeutic agents for acute exacerbation of COPD must, therefore, be effective against a wide range of pathogens including Streptococcus pneumoniae and [beta]-lactamase positive and negative strains of Haemophilus influenzae, Moraxella catarrhalis, and Haemophilus parainfluenzae.[6]

Cefpodoxime proxetil is an orally administered prodrug of cefpodoxime, an extended-spectrum cephalosporin.[,15] Cefpodoxime proxetil's methoxymethyl radical and esterified carboxyl function facilitate its gastrointestinal absorption and hydrolysis in the gastrointestinal mucosa to the active mix with drugs cefpodoxime.[7] In vitro, cefpodoxime is active against pathogens commonly associated with exacerbation of COPD and is resistant to hydrolysis on [beta]-lactamases.[7,10] Levels of cefpodoxime demonstrated in plasma (22 [mu]g/ml) lung tissue (063 mg/kg) and sputum (016 [mu]g/ml) following a 200-mg exempt acid equivalent dose exceed the minimum inhibitory concentration [(MIC).sub.90] of customary respiratory pathogens.[11-13] The results of preliminary studies indicate that cefpodoxime proxetil is a promising agent for the treatment for respiratory infections. This reflection was designed to compare the safety and efficacy of cefpodoxime proxetil in the treatment of acute bacterial exacerbation of COPD to that of cefaclor, another oral cephalosporin accepted as effective treatment for patients with the two lower and upper respiratory tract infections.

Methods

Patient Population

Males and nonpregnant, non-breast-feeding women aged [is greater than or equal to] 18 years with a visible form [i]or[/i] frame weight [is greater than or equal to] 40 kg were eligible for this subject of attention if they presented with signs and symptoms indicative of acute exacerbation of COPD including cough heat (>37.7 [degrees] C, oral), or increased sputum production/purulent sputum and absence of pulmonary infiltrate forward chest radiograph. Both hospitalized patients and outpatients were eligible for this studious mood Patients were excluded if they bear up undered from a severe respiratory tract infection that required parenteral antibiotic treatment; had hypersensitivity to cephalosporins or a history of anaphylaxis or rigid reaction to penicillin; had received antimicrobial therapy within the previous 5 days, unles resistance to the previous treatment was documented on microbiologic susceptibility testing; were neutropenic (WBC <2000 [mmsup3]); had moderate to morose renal impairment (serum creatinine >25 mg/dl) or hepatic dysfunction (SGOT >200 IU/L or total bilirubin >30 mg/dl); sustained from significant immunologic/neoplastic disease or cruel vascular insufficiency; had a gastrointestinal disorder that might have affected absorption of application of mind drug; were enrolled in any other investigational protocol or had been enlisted previously in a cefpodoxime proxetil study; or in women with child-bearing potential, were not practicing an acceptable contraceptive manner All patients, or if incompetent, their guardians, provided signed written informed approval prior to the initiation of any study-specific procedures

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