New Antibiotic Works In Bronchitis Flare-Up
SAN FRANCISCO—Clinical signs and symptoms of acute bacterial exacerbation of chronic bronchitis improved in patients treated with 5 days of an experimental ketolide antibiotic, cethromycin, or 7 days of levofloxacin, David A. Eiznhamer, Ph.D., reported.
The phase III, double-blind, multicenter trial randomized 509 outpatients aged 40 years or older to oral therapy with 150 mg of cethromycin per day or 500 mg of levofloxacin per day. Improvements at 14–19 days after enrollment were not significantly different between groups, but the investigators could not rule out the possibility, based on statistical analyses, that cethromycin might be inferior to levofloxacin at those doses, Dr. Eiznhamer said in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The lead investigator was S. Bukofzer of Abbott Laboratories, which is an investor in Advanced Life Sciences, and all of the investigators came from the two companies.
The 150-mg dose of cethromycin was chosen to minimize adverse events. A new study comparing a 300-mg daily dose of cethromycin with levofloxacin therapy is warranted, said Dr. Eiznhamer of Advanced Life Sciences, the company that is developing cethromycin.
The drug is also being studied in phase III trials for the treatment of community-acquired pneumonia. Advanced Life Sciences plans to submit a new drug application in 2007 with a goal of obtaining Food and Drug Administration approval in 2008, he said in an interview. The conference was sponsored by the American Society for Microbiology.
In an intent-to-treat analysis of 450 patients in the current study, clinical cure was seen in 81% of patients on cethromycin and 84% of those on levofloxacin. Clinical cure was defined as the resolution of at least one clinical symptom (dyspnea, sputum volume, purulence, cough, or fever) and improvement in at least half of the other symptoms.
An intent-to-treat analysis of overall pathogen eradication rates in 231 patients found eradication in 85% of the cethromycin group and 87% of the levofloxacin group.
For Streptococcus pneumoniae, however, cethromycin eradicated the organism in 14 (78%) of 18 patients, compared with 23 (92%) of 25 patients given levofloxacin.
