Who is sponsoring NCT01928433?

NCT01928433 is sponsored by MerLion Pharmaceuticals GmbH.

What drugs are being tested in NCT01928433?

Interventions in NCT01928433: Finafloxacin 800 mg i.v. once daily, Finafloxacin placebo i.v. once daily, Finafloxacin 800 mg tablets once daily, Finafloxacin placebo tablets once daily, Ciprofloxacin 400 mg i.v. twice daily, Ciprofloxacin placebo i.v. twice daily, Ciprofloxacin 500 mg oral twice daily, Ciprofloxacin placebo oral twice daily.

What condition does NCT01928433 study?

NCT01928433 studies Urinary Tract Infections, Acute Pyelonephritis.

Is NCT01928433 still recruiting?

NCT01928433 is currently completed. Last updated 6 April 2017.

Are results published for NCT01928433?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-04-06 · How we verify

NCT01928433

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Completed Phase 2 Results posted Last updated 6 April 2017

What this trial tests

Phase 2 trial testing Finafloxacin 800 mg i.v. once daily in Urinary Tract Infections in 225 participants. Completed in 1 October 2015.

Timeline

1 December 2012

Primary endpoint
1 June 2014

1 October 2015

Quick facts

Lead sponsor	MerLion Pharmaceuticals GmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	225
Start date	1 December 2012
Primary completion	1 June 2014
Estimated completion	1 October 2015
Sites	1 location across Germany

Drugs / interventions tested

Finafloxacin 800 mg i.v. once daily — full drug profile →
Finafloxacin placebo i.v. once daily — full drug profile →
Finafloxacin 800 mg tablets once daily
Finafloxacin placebo tablets once daily
Ciprofloxacin 400 mg i.v. twice daily — full drug profile →
Ciprofloxacin placebo i.v. twice daily — full drug profile →
Ciprofloxacin 500 mg oral twice daily — full drug profile →
Ciprofloxacin placebo oral twice daily

Conditions studied

Urinary Tract Infections — all drugs for Urinary Tract Infections →
Acute Pyelonephritis — all drugs for Acute Pyelonephritis →

Sponsor

MerLion Pharmaceuticals GmbH — full company profile →

Who can join

18 and older, any sex, with Urinary Tract Infections or Acute Pyelonephritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Clinical and Microbiological Response
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

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Considerations and Caveats in Combating ESKAPE Pathogens against Nosocomial Infections.
Ma YX, Wang CY, Li YY, Li J, et al · · 2020 · cited 170× · PMID 31921562 · DOI 10.1002/advs.201901872
Explorative Randomized Phase II Clinical Study of the Efficacy and Safety of Finafloxacin versus Ciprofloxacin for Treatment of Complicated Urinary Tract Infections.
Wagenlehner F, Nowicki M, Bentley C, Lückermann M, et al · · 2018 · cited 25× · PMID 29339395 · DOI 10.1128/aac.02317-17
Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates.
Vente A, Bentley C, Lückermann M, Tambyah P, et al · · 2018 · cited 12× · PMID 29339393 · DOI 10.1128/aac.02325-17
Antibacterials with Novel Chemical Scaffolds in Clinical Development.
Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x
Staph wars: the antibiotic pipeline strikes back.
Douglas EJA, Laabei M. · · 2023 · cited 10× · PMID 37656158 · DOI 10.1099/mic.0.001387
Population Pharmacokinetics of Finafloxacin in Healthy Volunteers and Patients with Complicated Urinary Tract Infections.
Taubert M, Lückermann M, Vente A, Dalhoff A, et al · · 2018 · cited 3× · PMID 29339394 · DOI 10.1128/aac.02328-17

Verify or expand the search:

Other recruiting trials for Urinary Tract Infections

Currently open trials in the same condition.

NCT06976125 — Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulat · NA · recruiting
NCT06808451 — Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture · NA · recruiting
NCT07186465 — Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis · Phase 4 · recruiting
NCT07207291 — Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers · Phase 1 · recruiting
NCT06715306 — Intravenous Versus Oral Treatment of the Main Acute Infections · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01928433 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MerLion Pharmaceuticals GmbH
Last refreshed: 6 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01928433.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing