Trial · NCT01928433
Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis
NCT01928433, Phase 2, Completed, MerLion Pharmaceuticals GmbH; results first posted 2017-06-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis. Trials, record NCT01928433. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01928433
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis
- NCT number
- NCT01928433
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 225 participants, actual
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Conditions
- Urinary Tract Infections, Acute Pyelonephritis
- Interventions
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
- First posted
- 2013-08-26
- Last updated
- 2017-06-20
- Other registries' IDs
- eudract:2011-006041-14
- Results first posted
- 2017-06-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical and Microbiological Response | 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 resolution of the symptoms of cUTI present at trial entry and no new symptoms developed. Microbiological response is defined as elimination or reduction of study entry pathogens to ≤ 10e3 CFU/mL on urine culture. The clinical and microbiological response will be assessed for each group on Day 17 and will be compared between the three groups to assess the efficacy in each group. |
| Secondary | Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3). | Day 3 | The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups. |
| Secondary | Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10). | Day 10 | The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups. |
| Secondary | Number of Participants With Clinical and Microbiological Response at the End of Study (EoS) Visit (Day 24). | Day 24 | The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups. |
| Secondary | The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Treatment-emergent Adverse Events | Screening to Day 24 | This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups. |
| Secondary | The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Participants Who Discontinued Due to TEAE | Screening to day 24 | This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical and Microbiological Response | Day 17 | The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3). | Day 3 | The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10). | Day 10 | The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical and Microbiological Response at the End of Study (EoS) Visit (Day 24). | Day 24 | The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Treatment-emergent Adverse Events | Screening to Day 24 | Safety (SAF) population includes all subjects with at least one administration of study drug. | Treatment-emergent AEs | NUMBER |
| SECONDARY | The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Participants Who Discontinued Due to TEAE | Screening to day 24 | Safety (SAF) population includes all subjects with at least one administration of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical and Microbiological Response | Finafloxacin 5 Days | 45 | Participants | ||
| Number of Participants With Clinical and Microbiological Response | Finafloxacin 10 Days | 46 | Participants | ||
| Number of Participants With Clinical and Microbiological Response | Ciprofloxacin 10 Days | 35 | Participants | ||
| Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3). | Finafloxacin 5 Days | 39 | Participants | ||
| Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3). | Finafloxacin 10 Days | 40 | Participants | ||
| Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3). | Ciprofloxacin 10 Days | 33 | Participants | ||
| Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10). | Finafloxacin 5 Days | 49 | Participants | ||
| Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10). | Finafloxacin 10 Days | 49 | Participants | ||
| Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10). | Ciprofloxacin 10 Days | 44 | Participants | ||
| Number of Participants With Clinical and Microbiological Response at the End of Study (EoS) Visit (Day 24). | Finafloxacin 5 Days | 47 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Finafloxacin 5 Days | 76 | |
| Overall Study | STARTED | Finafloxacin 10 Days | 75 | |
| Overall Study | STARTED | Ciprofloxacin 10 Days | 74 | |
| Overall Study | COMPLETED | Finafloxacin 5 Days | 56 | |
| Overall Study | COMPLETED | Finafloxacin 10 Days | 54 | |
| Overall Study | COMPLETED | Ciprofloxacin 10 Days | 46 | |
| Overall Study | NOT COMPLETED | Finafloxacin 5 Days | 20 | |
| Overall Study | NOT COMPLETED | Finafloxacin 10 Days | 21 | |
| Overall Study | NOT COMPLETED | Ciprofloxacin 10 Days | 28 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Finafloxacin 5 Days | 4 | 76 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Finafloxacin 10 Days | 3 | 75 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Ciprofloxacin 10 Days | 5 | 72 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Finafloxacin 5 Days | 2 | 76 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Finafloxacin 10 Days | 1 | 75 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Ciprofloxacin 10 Days | 3 | 72 | 3 |
| other | Nausea | Gastrointestinal disorders | Finafloxacin 5 Days | 5 | 76 | 5 |
| other | Nausea | Gastrointestinal disorders | Finafloxacin 10 Days | 1 | 75 | 1 |
| other | Nausea | Gastrointestinal disorders | Ciprofloxacin 10 Days | 1 | 72 | 1 |
| other | Blood pressure increased | Investigations | Finafloxacin 5 Days | 0 | 76 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Finafloxacin 5 Days | ||
| Total, all-cause mortality | Finafloxacin 10 Days | ||
| Total, all-cause mortality | Ciprofloxacin 10 Days | ||
| Total, other adverse events | Finafloxacin 5 Days | 29 | 76 |
| Total, other adverse events | Finafloxacin 10 Days | 19 | 75 |
| Total, other adverse events | Ciprofloxacin 10 Days | 29 | 72 |
| Total, serious adverse events | Finafloxacin 5 Days | 3 | 76 |
| Total, serious adverse events | Finafloxacin 10 Days | 4 | 75 |
| Total, serious adverse events | Ciprofloxacin 10 Days | 1 | 72 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01928433
GET https://conductscience.org/api/trials/v1/NCT01928433/events?page=2