Clinical Trial: Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Pyel

Brief 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.

Detailed Summary:
Sponsor: MerLion Pharmaceuticals GmbH

Current Primary Outcome: Clinical and microbiological response of patients with cUTI or pyelonephritis. [ Time Frame: Day 17 ]

The primary endpoint of this study is the clinical and microbiological response of patients with cUTI or pyelonephritis to treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days as a reference comparator at the Test of Cure (ToC) visit (Day 17) in the microbiological intent-to-treat population (micro-ITT population).

Clinical response is defined as resolution of the symptoms of cUTI present at trial entry and no new symptoms developed. Microbiological response is defined as Elimination or reduction of study entry pathogens to ≤ 10e3 CFU/mL on urine culture. The clinical and microbiological response will be assessed for each group on Day 17 and will be compared between the three groups to assess the efficacy in each group.

The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The clinical and microbiological response at the On Therapy (OT) visit (Day 3). [ Time Frame: Day 3 ]
    The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.
  • The clinical and microbiological response at the End of Therapy (EoT) visit (Day 10). [ Time Frame: Day 10 ]
    The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.
  • The clinical and microbiological response at the End of Study (EoS) visit (Day 24). [ Time Frame: Day 24 ]
    The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.
  • The safety and tolerability of multiple doses of finafloxacin of both 5 days and 10 days of treatment with finafloxacin (i.v. and oral) in subjects with cUTI, compared to 10 days of ciprofloxacin (i.v. and oral). [ Time Frame: Screening to Day 24 ]
    This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups.
  • The predictive capacity of PK/PD data of both 5 days and 10 days of treatment with finafloxacin (i.v. and oral) in subjects with cUTI, using 10 days of ciprofloxacin (i.v. and oral) as reference on clinical outcomes (EMA guidance). [ Time Frame: Day 5 and 10 ]
    Blood samples will be collected from all patients enrolled in the study and urine samples will be collected in a subset of 25 patients per treatment arm at visit 2 (Day 3). Pharmacokinetic parameters to be evaluated include: AUC, Cmax, Tmax and others. The pharmacokinetic parameters determined on Day 3 of the study will be compared with the clinical signs observed on Day 3 in order to evaluate any correlations between these two data sets and therefore, to evaluate, if the PK/PD data demonstrate a predictive capacity with regard to the clinical signs assessed.


Original Secondary Outcome: Same as current

Information By: MerLion Pharmaceuticals GmbH

Dates:
Date Received: July 17, 2013
Date Started: December 2012
Date Completion:
Last Updated: March 1, 2016
Last Verified: April 2015