SAN FRANCISCO — An experimental fluoroquinolone compared favorably with amoxicillin or ceftriaxone for the treatment of community-acquired pneumonia in separate randomized, double-blind phase III trials, investigators reported in poster presentations at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
One study of 308 outpatients in Europe and Russia with mild to moderate community-acquired pneumonia showed similar response rates in patients given 5 days of oral garenoxacin or 10 days of oral amoxicillin, reported Dr. Hetty Waskin of Schering-Plough Research Institute, Kenilworth, N.J. The company is developing garenoxacin and funded the study. The lead investigator in the study was Dr. N. Mogulkoc of Ege University, Izmir, Turkey.
Evaluations that were conducted 7–14 days after completing therapy showed clinical responses in 91% of patients randomized to once-daily doses of 400 mg garenoxacin and in 87% of patients given amoxicillin 1 g t.i.d. The drugs eradicated pneumonia bacteria in 88% of the garenoxacin group and 91% of the amoxicillin group.
Drug-related adverse events—most commonly diarrhea, headache, abdominal pain, and nausea—were seen in 13% of patients in the garenoxacin group and 12% of those in the amoxicillin group.
The second study of 406 hospitalized patients with community-acquired pneumonia showed an 88% clinical cure rate in 328 evaluable patients regardless of treatment group. Patients were randomized to receive either IV garenoxacin 400 mg/day with possible step-down to oral garenoxacin 400 mg/day or IV ceftriaxone 1–2 g/day with possible step-down to oral clarithromycin 500 mg b.i.d. If clinicians suspected atypical pneumonia, patients in the ceftriaxone group also could receive IV erythromycin 0.5–1 g every 6 hours.
Patients were treated for 7–14 days and evaluated for cure 7–14 days after completing therapy, said Dr. Mark E. Dowell of Casper, Wyo., the study's primary investigator. He has no other relationship with Schering-Plough except that the company funded the study and a company employee (Dr. Waskin) was a coinvestigator.
Bacterial eradication rates were 86% for the garenoxacin group and 89% for the ceftriaxone group.
Schering-Plough hopes to win European approval for the drug for community-acquired pneumonia in 2007, but will be looking for a marketing partner to pursue approval of the drug in the United States, Dr. Waskin said.
The conference was sponsored by the American Society for Microbiology.