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.

Conditions

• Urinary Tract Infections
• Acute Pyelonephritis

Interventions

DRUG

Finafloxacin 800 mg i.v. once daily

Infused over 60 mins \[i.v. pump\]) for at least 3 days.

DRUG

Finafloxacin placebo i.v. once daily

Infused over 60 mins \[i.v. pump\]) for at least 3 days.

DRUG

Finafloxacin 800 mg tablets once daily

Administered as four 200 mg tablets

DRUG

Finafloxacin placebo tablets once daily

Administered as four tablets

DRUG

Ciprofloxacin 400 mg i.v. twice daily

Infused over approximately 60 mins \[i.v. pump\]) for at least 3 days

DRUG

Ciprofloxacin placebo i.v. twice daily

Infused over approximately 60 mins \[i.v. pump\]) for at least 3 days

DRUG

Ciprofloxacin 500 mg oral twice daily

Administered as two 250 mg capsules.

DRUG

Ciprofloxacin placebo oral twice daily

Administered as two capsules.

Sponsors & Collaborators

• MerLion Pharmaceuticals GmbH

  lead INDUSTRY

Principal Investigators

• Florian Wagenlehner, Prof. · Germany: University Hospital Giessen and Marburg, Department of Urology

• Michal Nowicki, Prof. · Poland: Medical University Lodz, Department of Nephrology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2014-06-30

Completion

2015-10-31

Countries

• Germany

Study Locations