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NCT00722735: FLUT
A Double-Blind, Double-Dummy, Prospective, Randomized Multiple-Site Study of Oral Finafloxacin 300 mg b.i.d. Versus Oral Ciprofloxacin 250 mg b.i.d. in Patients With Lower Uncomplicated UTI (uUTI) With a Treatment Duration of 3 Days
Phase 2 trial testing Finafloxacin in Urinary Tract Infections in 36 participants. Completed in 1 April 2009.
1 April 2009
Quick facts
| Lead sponsor | MerLion Pharmaceuticals GmbH |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 October 2008 |
| Primary completion | 1 April 2009 |
| Estimated completion | 1 April 2009 |
| Sites | 2 locations across Germany, Singapore |
Drugs / interventions tested
- Finafloxacin (FINAFLOXACIN) — full drug profile →
- Ciprofloxacin (Ciprofloxacin) — full drug profile →
Conditions studied
- Urinary Tract Infections — all drugs for Urinary Tract Infections →
Sponsor
MerLion Pharmaceuticals GmbH — full company profile →
Who can join
Adults 18 to 55, female only, with Urinary Tract Infections. 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.
-
Bacteriological eradication of the initial pathogen.
Time frame: 4-6 days
Sponsor's own description
To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.
Publications & conference data
3 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 -
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
Verify or expand the search:
- PubMed search for NCT00722735
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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)
- Trial protocol + status: ClinicalTrials.gov NCT00722735 (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: 10 June 2009
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/NCT00722735.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing