Conditions: Urinary Tract Infections Acute Pyelonephritis
Keywords: Urinary Tract Infection Pyelonephritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 225
Healthy volunteers: no

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.

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.

Arms:
arm 1: Intervention:

Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 5 days. arm 2: Intervention:

Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 10 days. arm 3: Intervention:

Ciprofloxacin 400 mg i.v. twice daily and Finafloxacin placebo i.v. once daily Ciprofloxacin 500 mg oral twice daily and Finafloxacin placebo tablets once daily Ciprofloxacin (i.v. and oral) for a total of 10 days.

Interventions: intervention 1: Finafloxacin 800 mg i.v. once daily intervention 2: Finafloxacin placebo i.v. once daily intervention 3: Finafloxacin 800 mg tablets once daily intervention 4: Finafloxacin placebo tablets once daily intervention 5: Ciprofloxacin 400 mg i.v. twice daily intervention 6: Ciprofloxacin placebo i.v. twice daily intervention 7: Ciprofloxacin 500 mg oral twice daily intervention 8: Ciprofloxacin placebo oral twice daily
Intervention descriptions: intervention 1: Infused over 60 mins \[i.v. pump\]) for at least 3 days. intervention 2: Infused over 60 mins \[i.v. pump\]) for at least 3 days. intervention 3: Administered as four 200 mg tablets intervention 4: Administered as four tablets intervention 5: Infused over approximately 60 mins \[i.v. pump\]) for at least 3 days intervention 6: Infused over approximately 60 mins \[i.v. pump\]) for at least 3 days intervention 7: Administered as two 250 mg capsules. intervention 8: Administered as two capsules.

Protocol document: