Evidence map›Paper›PMID 29339395›Full record

Trial reportAntimicrobial agents and chemotherapy2018

Explorative Randomized Phase II Clinical Study of the Efficacy and Safety of Finafloxacin versus Ciprofloxacin for Treatment of Complicated Urinary Tract Infections.

F Wagenlehner, M Nowicki, C Bentley, M Lückermann, S Wohlert, C Fischer, A Vente, K Naber, A Dalhoff

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01928433 (A Multi-Dose, Double-Blind, Double-Dummy, Active- Control, Randomized Clinical), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01928433 phase2completednot on this map

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.

TypeinterventionalSponsorMerLion Pharmaceuticals GmbHRan2012 to 2015Enrolled225ConditionsUrinary Tract Infections, Acute PyelonephritisArmsFinafloxacin 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
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Staph wars: the antibiotic pipeline strikes back.Microbiology (Reading, England) · 2023
    Review
  5. Antibiotics (Basel, Switzerland) · 2023
    Article
  6. Cells · 2023
    Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Considerations and Caveats in Combating ESKAPE Pathogens against Nosocomial Infections.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2020
    Review
  14. Demonstration of the broad spectrumAntimicrobial agents and chemotherapy · 2019
    Article
  15. Review
  16. Article
  17. Urinary Tract Infection in Children.Recent patents on inflammation & allergy drug discovery · 2019
    Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

F WagenlehnerJustus Liebig University, Clinic of Urology, Pediatric Urology and Andrology, Gießen, Germany Florian.Wagenlehner@chiru.med.uni-giessen.de.
M NowickiMedical University of Lodz, Department of Nephrology, Hypertension and Kidney Transplantation, Lodz, Poland.
C BentleyMerLion Pharmaceuticals, Berlin, Germany.
M LückermannMerLion Pharmaceuticals, Berlin, Germany.
S WohlertMerLion Pharmaceuticals, Berlin, Germany.
C FischerMerLion Pharmaceuticals, Berlin, Germany.
A VenteMerLion Pharmaceuticals, Berlin, Germany.
K NaberTechnical University Munich, Department of Urology, Munich, Germany.
A DalhoffUniversity Medical Center Schleswig-Holstein, Institute for Infection Medicine, Kiel, Germany.
MerLion Pharma (Germany) · DEMedical University of Lodz · PLTechnical University of Munich · DEUniversity of Giessen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The broad-spectrum C-8-cyano-fluoroquinolone finafloxacin displays enhanced activity under acidic conditions. This phase II clinical study compared the efficacies and safeties of finafloxacin and ciprofloxacin in patients with complicated urinary tract infection and/or pyelonephritis. A 5-day regimen with 800 mg finafloxacin once a day (q.d.) (FINA05) had results similar to those of a 10-day regimen with 800 mg finafloxacin q.d. (FINA10). Combined microbiological and clinical responses at the test-of-cure (TOC) visit were 70% for FINA05, 68% for FINA10, and 57% for a 10-day ciprofloxacin regimen (CIPRO10) in 193 patients (64 for FINA05, 68 for FINA10, and 61 for CIPRO10) of the microbiological intent-to-treat (mITT) population. Additionally, the clinical effects of ciprofloxacin on patients with an acidic urine pH (80% of patients) were reduced, whereas the effects of finafloxacin were unchanged. Finafloxacin was safe and well tolerated. Overall, 43.4% of the patients in the FINA05 group, 42.7% in the FINA10 group, and 54.2% in the CIPRO10 group experienced mostly mild and treatment-emergent but unrelated adverse events. A short-course regimen of 5 days of finafloxacin resulted in high eradication and improved clinical outcome rates compared to those for treatment with ciprofloxacin for 10 days. In contrast to those of ciprofloxacin, the clinical effects of finafloxacin were not reduced by acidic urine pH. Hospitalized adults were randomized 1:1:1 to finafloxacin treatment (800 mg q.d.) for either 5 or 10 days or to ciprofloxacin treatment (400 mg/500 mg b.i.d.) for 10 days with an optional switch from intravenous (i.v.) to oral administration at day 3. The primary endpoint was the combined microbiological and clinical response at the TOC visit in the microbiological intent-to-treat population. (This study has been registered at ClinicalTrials.gov under identifier NCT01928433.).

Indexed as

Administration, IntravenousAdministration, OralAdultAgedAnti-Bacterial AgentsCiprofloxacinFemaleFluoroquinolonesHumansMaleMiddle AgedPyelonephritisUrinary Tract InfectionsAnti-Bacterial AgentsCiprofloxacinfinafloxacinFluoroquinolonesacidic urinecomplicated urinary tract infectionfinafloxacinpyelonephritistreatment duration

Identifiers

PMID29339395
PMCPMC5913919
OpenAlexW2791093118

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.