NCT01928433

Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis

A Multi-Dose, Double-Blind, Double-Dummy, Active- Control, Randomized Clinical (Phase II) Study of Two Dosing Regimens of Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis Requiring Hospitalisation.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: MerLion Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fluoroquinolones are frequently prescribed for complicated Urinary Tract Infections (cUTI) and pyelonephritis, due to their activity against cUTI pathogens and high levels of excretion in the urine following oral and i.v. administration. However, many currently prescribed fluoroquinolones exhibit reduced antibacterial activity at low pH, which suggests reduced activity in infected urinary tracts.

Conditions

• Urinary Tract Infections
• Acute Pyelonephritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-06-01
• Completion: 2015-10-01
• First posted: 2013-08-26
• Last updated: 2017-06-20
• Results posted: 2017-06-20

Locations

1 site across 1 country: Germany