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Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infection and pyelonephritis.
Antimicrob Agents Chemother. 2009 Sep; 53(9):3782-92.AA

Abstract

The prospective, multicenter, double-blind study presented in this report evaluated whether or not intravenous (IV) administration of doripenem, a carbapenem with bactericidal activity against gram-negative and gram-positive uropathogens, is inferior to IV administration of levofloxacin in the treatment of complicated urinary tract infection (cUTI). Patients (n = 753) with complicated lower UTI or pyelonephritis were randomly assigned to receive IV doripenem at 500 mg every 8 h (q8h) or IV levofloxacin at 250 mg q24h. Patients in both treatment arms were eligible to switch to oral levofloxacin after 3 days of IV therapy to complete a 10-day treatment course if they demonstrated significant clinical and microbiological improvements. The microbiological cure rate (primary end point) was determined at the test-of-cure (TOC) visit occurring 5 to 11 days after the last dose of antibiotic. For the microbiologically evaluable patients (n = 545), the microbiological cure rates were 82.1% and 83.4% for doripenem and levofloxacin, respectively (95% confidence interval [CI] for the difference, -8.0 to 5.5%); in the microbiological modified intent-to-treat cohort (n = 648), the cure rates were 79.2% and 78.2%, respectively. Clinical cure rates at the TOC visit were 95.1% in the doripenem arm and 90.2% in the levofloxacin arm (95% CI around the difference in cure rates [doripenem cure rate minus levofloxacin cure rate], 0.2% to 9.6%). Both treatment regimens were generally well tolerated. Doripenem was found not to be inferior to levofloxacin in terms of therapeutics and is now approved for use in the United States and Europe for the treatment of adults with cUTI, including pyelonephritis. As fluoroquinolone resistance increases, doripenem may become a more important option for successful treatment of cUTIs, including treatment of pyelonephritis.

Authors+Show Affiliations

Technical University of Munich, Munich, Germany. kurt.naber@nabers.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19581455

Citation

Naber, K G., et al. "Intravenous Doripenem at 500 Milligrams Versus Levofloxacin at 250 Milligrams, With an Option to Switch to Oral Therapy, for Treatment of Complicated Lower Urinary Tract Infection and Pyelonephritis." Antimicrobial Agents and Chemotherapy, vol. 53, no. 9, 2009, pp. 3782-92.
Naber KG, Llorens L, Kaniga K, et al. Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infection and pyelonephritis. Antimicrob Agents Chemother. 2009;53(9):3782-92.
Naber, K. G., Llorens, L., Kaniga, K., Kotey, P., Hedrich, D., & Redman, R. (2009). Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infection and pyelonephritis. Antimicrobial Agents and Chemotherapy, 53(9), 3782-92. https://doi.org/10.1128/AAC.00837-08
Naber KG, et al. Intravenous Doripenem at 500 Milligrams Versus Levofloxacin at 250 Milligrams, With an Option to Switch to Oral Therapy, for Treatment of Complicated Lower Urinary Tract Infection and Pyelonephritis. Antimicrob Agents Chemother. 2009;53(9):3782-92. PubMed PMID: 19581455.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intravenous doripenem at 500 milligrams versus levofloxacin at 250 milligrams, with an option to switch to oral therapy, for treatment of complicated lower urinary tract infection and pyelonephritis. AU - Naber,K G, AU - Llorens,L, AU - Kaniga,K, AU - Kotey,P, AU - Hedrich,D, AU - Redman,R, Y1 - 2009/07/06/ PY - 2009/7/8/entrez PY - 2009/7/8/pubmed PY - 2009/11/6/medline SP - 3782 EP - 92 JF - Antimicrobial agents and chemotherapy JO - Antimicrob Agents Chemother VL - 53 IS - 9 N2 - The prospective, multicenter, double-blind study presented in this report evaluated whether or not intravenous (IV) administration of doripenem, a carbapenem with bactericidal activity against gram-negative and gram-positive uropathogens, is inferior to IV administration of levofloxacin in the treatment of complicated urinary tract infection (cUTI). Patients (n = 753) with complicated lower UTI or pyelonephritis were randomly assigned to receive IV doripenem at 500 mg every 8 h (q8h) or IV levofloxacin at 250 mg q24h. Patients in both treatment arms were eligible to switch to oral levofloxacin after 3 days of IV therapy to complete a 10-day treatment course if they demonstrated significant clinical and microbiological improvements. The microbiological cure rate (primary end point) was determined at the test-of-cure (TOC) visit occurring 5 to 11 days after the last dose of antibiotic. For the microbiologically evaluable patients (n = 545), the microbiological cure rates were 82.1% and 83.4% for doripenem and levofloxacin, respectively (95% confidence interval [CI] for the difference, -8.0 to 5.5%); in the microbiological modified intent-to-treat cohort (n = 648), the cure rates were 79.2% and 78.2%, respectively. Clinical cure rates at the TOC visit were 95.1% in the doripenem arm and 90.2% in the levofloxacin arm (95% CI around the difference in cure rates [doripenem cure rate minus levofloxacin cure rate], 0.2% to 9.6%). Both treatment regimens were generally well tolerated. Doripenem was found not to be inferior to levofloxacin in terms of therapeutics and is now approved for use in the United States and Europe for the treatment of adults with cUTI, including pyelonephritis. As fluoroquinolone resistance increases, doripenem may become a more important option for successful treatment of cUTIs, including treatment of pyelonephritis. SN - 1098-6596 UR - https://www.unboundmedicine.com/medline/citation/19581455/Intravenous_doripenem_at_500_milligrams_versus_levofloxacin_at_250_milligrams_with_an_option_to_switch_to_oral_therapy_for_treatment_of_complicated_lower_urinary_tract_infection_and_pyelonephritis_ DB - PRIME DP - Unbound Medicine ER -