At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating Finafloxacin 800 mg i.v. once daily, Finafloxacin placebo i.v. once daily, and 6 other interventions for Urinary Tract Infections and Acute Pyelonephritis. Completed, enrolled 225 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Infused over 60 mins \[i.v. pump\]) for at least 3 days.
Infused over 60 mins \[i.v. pump\]) for at least 3 days.
Administered as four 200 mg tablets
Administered as four tablets
Infused over approximately 60 mins \[i.v. pump\]) for at least 3 days
Infused over approximately 60 mins \[i.v. pump\]) for at least 3 days
Administered as two 250 mg capsules.
Administered as two capsules.