Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis

Summary

The primary objective of this study is to evaluate the microbiological and clinical outcome of treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days as a reference comparator. Finafloxacin shows increased activity in an acidic environment which is associated with indications such as uUTI and cUTI. Given the acidic pH of urine and concentration of finafloxacin excreted via the urinary tract in humans it should be proven if the finafloxacin treatments offer significant advantages over the currently available treatments for UTI.

Timeline

Start

2012-12

Primary completion

2014-06

Completion

2015-10

Publications

• Wagenlehner F, Nowicki M, Bentley C, Luckermann M, Wohlert S, Fischer C, Vente A, Naber K, Dalhoff A. Explorative Randomized Phase II Clinical Study of the Efficacy and Safety of Finafloxacin versus Ciprofloxacin for Treatment of Complicated Urinary Tract Infections. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02317-17. doi: 10.1128/AAC.02317-17. Print 2018 Apr.
• Taubert M, Luckermann M, Vente A, Dalhoff A, Fuhr U. Population Pharmacokinetics of Finafloxacin in Healthy Volunteers and Patients with Complicated Urinary Tract Infections. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02328-17. doi: 10.1128/AAC.02328-17. Print 2018 Apr.
• Vente A, Bentley C, Luckermann M, Tambyah P, Dalhoff A. Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02325-17. doi: 10.1128/AAC.02325-17. Print 2018 Apr.

Drugs

Indications