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Doripenem Proves Noninferior to Levofloxacin in Complicated Urinary Tract Infections: Presented at ICAAC

By Ed Susman

SAN FRANCISCO -- September 13, 2009 -- The broad-spectrum carbapenem antibiotic doripenem appears to be noninferior to the quinolone levofloxacin in treating patients diagnosed with complicated urinary tract infections, researchers said here at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Doripenem also appeared to be more effective in treating infections caused by bacteria that were resistant to levofloxacin, said Kurt Naber, MD, Technical University of Munich, Munich, Germany, at a poster presentation on September 12.

"The bottom line in this study," said Dr. Naber, "is that doripenem is as good as treating these infections as levofloxacin but is better than levofloxacin when dealing with resistant bacteria."

"Intravenous infusion of doripenem, 500 mg over 1 hour every 8 hours, was microbiologically and clinically effective in the treatment of complicated urinary tract infections and was therapeutically noninferior to intravenous levofloxacin 250 mg every 24 hours," he said.

In the study, researchers pooled results of 2 multicentre, international phase 3 studies in which 803 patients were assigned to treatment with doripenem and 376 patients were assigned to receive levofloxacin. In the microbiological modified intent-to-treat analysis, 664 patients receiving doripenem and 321 patients receiving levofloxacin were analysed.

Dr. Naber said 82.1% of patients treated with doripenem achieved microbiologic cure rates compared with 79.2% with levofloxacin in 1 study, and 83.6% of patients receiving doripenem and 82.5% of patients treated with levofloxacin achieved microbiologic cure rates in the second study. The differences were not statistically different, Dr. Naber said, but achieved noninferiority for doripenem.

He said that among patients infected with levofloxacin-resistant Escherichia coli the clinical cure rate with doripenem was 95.1% of 41 patients compared with 50% of the 16 patients with resistant bacteria treated with levofloxacin.

"Patients at risk for infection with fluoroquinolone-resistant E coli may benefit from empirical treatment with doripenem," Dr. Haber said.

The patients in the studies were about 51 years of age and about 40% of them were men. About 10% in each group had bacteraemia at baseline. About half the people in each group had normal renal function.

Funding for this study was provided by Johnson & Johnson Pharmaceutical Research and Development.

[Presentation title: Efficacy of Doripenem Versus Levofloxacin for the Treatment of Complicated Urinary Tract Infections. Abstract L1-340]

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