Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis

PHASE2CompletedINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

June 30, 2014

Study Completion Date

October 31, 2015

Conditions
Urinary Tract InfectionsAcute 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.

Trial Locations (1)

35392

Universitätsklinikum Giessen, Klinik für Urologie, Kinderurologie und Andrologie, Giessen

Sponsors
All Listed Sponsors
lead

MerLion Pharmaceuticals GmbH

INDUSTRY

NCT01928433 - Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis | Biotech Hunter | Biotech Hunter