Urinary Tract InfectionsPhase 2NCT01928433
Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis
A Phase 2 study testing Finafloxacin 800 mg i.v. once daily, Finafloxacin 800 mg tablets once daily and Ciprofloxacin 400 mg i.v. twice daily in people with Urinary Tract Infections and Acute Pyelonephritis, run by MerLion Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Acute Pyelonephritis
- What is being tested?
- Finafloxacin 800 mg i.v. once daily, Finafloxacin 800 mg tablets once daily and Ciprofloxacin 400 mg i.v. twice daily
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Oct 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be male or female subjects ≥ 18 years of age.
- If a female and
- subject is of childbearing potential, must have documented use of using an effective contraceptive method (such as IUD, hormonal birth control, condom and spermicidal jelly, etc.) during the study, Contraception must have been used for at least 2 months before starting the study. A documented negative urine pregnancy test must be provided and the subject must be non-lactating.
- subject is of non-childbearing potential, must be post-menopausal (i.e. has had amenorrhea for a minimum of 12 consecutive months) or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
- subject is truly abstinent. This is accepted as a method of contraception, but only when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- If a male, should agree to use reliable birth control methods (contraception or other barrier device) during study participation.
Show all 29Show fewer
- Must have complicated lower urinary tract infection or acute complicated or uncomplicated pyelonephritis (cPN or uPN; see section 5.3) and must have at least two of the following acute signs and symptoms
- Chills or rigors or warmth associated with fever (e.g. oral temperature greater than 38.0 degrees Celsius ).
- Flank pain (pyelonephritis) or pelvic pain (cUTI).
- Nausea or vomiting.
- Dysuria, urinary frequency, or urinary urgency.
- Costo-vertebral angle tenderness (pyelonephritis) on physical examination.
- Provide one pre-treatment adequate urine sample (the urine sample must return a positive culture in order for the subject to remain eligible for the study) For males: midstream clean catch, for females: in-out catheterisation or midstream clean catch. The urine sample must be provided within 24 hours before the start of administration of the first dose of study drug.
- A positive urine culture is defined as:
- ≥ 105 CFU/mL of one causative pathogen in the case of cUTI
- ≥ 104 CFU/mL of one causative pathogen in case of Pyelonephritis
- A negative urine culture is defined as:
- < 105 CFU/mL of causative pathogen/s and/or non-target pathogens at any number of CFUs in the case of cUTI
- < 104 CFU/mL of causative pathogen/s and/or non-target pathogens at any number of CFUs in the case of Pyelonephritis Patients may be admitted to the study pending baseline urine culture results. Treatment should NOT be delayed pending urine culture results.
- NOTE: Because biofilms on indwelling catheters (e.g. Foley catheters) are more likely to be present after the catheter has been in place for a period of time, samples should be collected following the placement of a new catheter. If the placement of a new catheter is contraindicated or is not feasible, specimens should be collected using aseptic techniques with the urine obtained through a properly disinfected collection port. Urine samples should never be obtained from the collection bag.
- If the subject's pre-treatment culture shows the presence of a ciprofloxacin resistant pathogen the Investigator has to decide according to clinical signs and symptoms whether the subject can stay in the study.
- In the event of a negative urine culture, the subject must be withdrawn from the study and switched to standard care, because the inclusion criterion is not fulfilled.
- A urine culture is defined as contaminated if:
- at least one causative pathogen with ≥ 105 CFU/mL is present AND at least one non-pathogen or additional causative pathogen/s at any number of CFU/mL are present in the case of cUTI
- at least one causative pathogen with ≥ 104 CFU/mL is present AND at least one non-pathogen or additional causative pathogen/s with any number of CFU/mL in the case of pyelonephritis Subjects with contaminated urine cultures will be permitted to continue in the study, although this will impact on the subject's eligibility for analysis (see section 9.3).
- Have pyuria (i.e. a dipstick analysis positive for leukocyte esterase or at least 10 white blood cells per cubic millimetre [1 µl]).
- Be considered ill enough to be hospitalized for at least 3 days and require initial parenteral therapy to manage cUTI and/or acute pyelonephritis by the standard of care.
- Provide written informed consent to participate in the study.
- Be willing and able to comply with all study procedures and activities.
Who cannot join
- Uncomplicated cystitis in females.
- Failed previous antibiotic treatment within the last 4 weeks due to culture confirmed fluoroquinolone resistant pathogens.
- Having ileal loops, urinary diversion with bowel segments or suspected or confirmed vesico-ureteral reflux, suspected or confirmed perinephric or intrarenal abscess (if an abscess is suspected an ultrasound should be performed to confirm and exclude).
- History of renal transplant any permanent complicating factors of the urinary tract (including complete obstruction, suspected or confirmed prostatitis or epididymitis) which cannot be effectively treated during the therapy of the infection.
- Indwelling urinary catheters expected to remain in place after therapy has been completed.
- The urinary tract infection or any other concomitant bacterial infection that requires systemic antibiotic therapy (in addition to the study treatment) at the time of randomisation. Antibiotics with only gram-positive activity are permitted.
Show all 32Show fewer
- Any infection that, in the opinion of the Investigator, would be considered intractable and likely to require more than 10 days of study drug therapy.
- Any recent use (e.g., within 48 hours before the first dose of study medication) of an antimicrobial therapy with a drug that has activity in the treatment of urinary tract infection.
- Having been exposed to any fluoroquinolone in the 30 days before Day 1 (study enrolment), previous participation in a finafloxacin clinical trial or participation within the last 30 days in any other clinical study in general.
- In the 12 months before study enrolment: known uncontrolled condition of hypertension or symptomatic hypotension, known uncontrolled cardiac arrhythmia, known ischaemic heart disease or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty.
- Significantly immunocompromised (defined as a WBC < 1000) and/or having a known infection with human immunodeficiency virus (HIV/AIDS), any haematological malignancy, bone marrow transplantation, or current immunosuppressive therapy (including but not limited to cancer chemotherapy, or medications for prevention of organ transplantation rejection).
- Any concomitant psychiatric, neurological or behavioural disorder, including epilepsy or other lesions of the central nervous system sufficient in the opinion of the Investigator to prevent or compromise the subject's participation in the study.
- Any known concomitant bacterial or fungal sexually transmitted disease with the exception of candidiasis.
- Having, in the opinion of the Investigator, any clinically significant serious or unstable physical illness likely to impact on the subject's wellbeing or the conduct and analysis of the study, including, but not limited to, acute hepatic failure, respiratory failure, severe, persistent diarrhoea and septic shock.
- Any surgical or medical condition which might interfere with the distribution, metabolism or excretion of the drug, including, but not limited to moderate (including estimated creatinine clearance of 30 - 59 mL/min) or severe impairment of renal function (including an estimated creatinine clearance of < 30 mL/min), requirement for peritoneal dialysis, haemodialysis or haemofiltration, or oliguria.
- Any malignant disease or a history of malignant neoplasm requiring a treatment with immune suppressive properties in the 6 months before baseline.
- Known history of drug abuse.
- Clinically abnormal haematology, biochemistry and urinalysis results at baseline including, but not limited to:
- AST, ALT, or alkaline phosphatase level greater than 3 times the upper limit of normal (ULN).
- Total bilirubin greater than 2 times ULN.
- WBC count less than 1000/μL, platelet count less than 50,000/μL.
- Haematocrit less than 25%.
- Creatinine clearance < 60mL/minute.
- Any clinically significant ECG abnormality on the baseline ECG subjects at risk for torsade de pointes arrhythmia or a history of significant or inadequately treated cardiac disease.
- Documented history of hypersensitivity or allergy to or known contraindication to the use of fluoroquinolones.
- Any history of tendon lesions or ruptures either during quinolone treatment or for any other reason.
- Concomitant tizanidine use.
- Any administration of corticosteroids equivalent to or greater than 20 mg of prednisone per day for more than 14 days before randomisation.
- The subject, planned to be enrolled is an employee or relative of any involved study Investigator or any involved institution including MerLion or Galenus.
- Life expectancy of less than 3 months.
- Women who are pregnant or nursing.
- Any other condition that, in the opinion of the Investigator, would prevent the subject from effectively participating in the study, place the subject at risk or affect the assessment of efficacy and safety of the study medication.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Giessen, Klinik für Urologie, Kinderurologie und Andrologie
Giessen, 35392
About this study
Official title: 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.
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.
Read the detailed description
Fluoroquinolones are frequently prescribed for complicated Urinary Tract Infections (cUTI) and pyelonephritis, due to their activity against cUTI pathogens and high levels of excretion in the urine following oral and i.v. administration. However, many currently prescribed fluoroquinolones exhibit reduced antibacterial activity at low pH, which suggests reduced activity in infected urinary tracts.
- Conditions
- Urinary Tract Infections, Acute Pyelonephritis
- Being tested
- 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
- Keywords
- Urinary Tract Infection, Pyelonephritis
- Medical subject headings
- Urinary Tract Infections, Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finafloxacin 800 mg i.v. once dailyDrug
Also called Finafloxacin
Infused over 60 mins [i.v. pump]) for at least 3 days.
Finafloxacin placebo i.v. once dailyDrug
Also called Saline
Infused over 60 mins [i.v. pump]) for at least 3 days.
Finafloxacin 800 mg tablets once dailyDrug
Also called Finafloxacin
Administered as four 200 mg tablets
Finafloxacin placebo tablets once dailyDrug
Administered as four tablets
Ciprofloxacin 400 mg i.v. twice dailyDrug
Also called Ciprofloxacin Kabi Infusionslösung
Infused over approximately 60 mins [i.v. pump]) for at least 3 days
Ciprofloxacin placebo i.v. twice dailyDrug
Also called Saline
Infused over approximately 60 mins [i.v. pump]) for at least 3 days
Ciprofloxacin 500 mg oral twice dailyDrug
Also called Ciprofloxacin real 250/500/750 mg
Administered as two 250 mg capsules.
Ciprofloxacin placebo oral twice dailyDrug
Administered as two capsules.
| Study group | Role | What they receive |
|---|---|---|
| Finafloxacin 5 days | Experimental | Intervention:
Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 5 days. Receives: Drug: Finafloxacin 800 mg i.v. once daily; Drug: Finafloxacin 800 mg tablets once daily; Drug: Ciprofloxacin placebo i.v. twice daily; Drug: Ciprofloxacin placebo oral twice daily |
| Finafloxacin 10 days | Experimental | Intervention:
Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 10 days. Receives: Drug: Finafloxacin 800 mg i.v. once daily; Drug: Finafloxacin 800 mg tablets once daily; Drug: Ciprofloxacin placebo i.v. twice daily; Drug: Ciprofloxacin placebo oral twice daily |
| Ciprofloxacin 10 days | Active comparator | Intervention:
Ciprofloxacin 400 mg i.v. twice daily and Finafloxacin placebo i.v. once daily Ciprofloxacin 500 mg oral twice daily and Finafloxacin placebo tablets once daily Ciprofloxacin (i.v. and oral) for a total of 10 days. Receives: Drug: Finafloxacin placebo i.v. once daily; Drug: Finafloxacin placebo tablets once daily; Drug: Ciprofloxacin 400 mg i.v. twice daily; Drug: Ciprofloxacin 500 mg oral twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical and Microbiological Response
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.
Measured: Day 17
Secondary outcomes (5)
Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (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.
Measured: Day 3
Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (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.
Measured: Day 10
Number of Participants With Clinical and Microbiological Response at the End of Study (EoS) Visit (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.
Measured: Day 24
The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Treatment-emergent Adverse Events
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.
Measured: Screening to Day 24
The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Participants Who Discontinued Due to TEAE
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.
Measured: Screening to day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Wagenlehner, Prof., Principal investigator, Germany: University Hospital Giessen and Marburg, Department of UrologyMichal Nowicki, Prof., Principal investigator, Poland: Medical University Lodz, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928433
- Sponsor's protocol ID
- FINA-007
- Other IDs
- 2011-006041-14
- Status last verified
- Apr 2017
- First submitted
- 17 Jul 2013
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wagenlehner F, Nowicki M, Bentley C, Luckermann M, Wohlert S, Fischer C, Vente A, Naber K, Dalhoff A. Explorative Randomized Phase II Clinical Study of the Efficacy and Safety of Finafloxacin versus Ciprofloxacin for Treatment of Complicated Urinary Tract Infections. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02317-17. doi: 10.1128/AAC.02317-17. Print 2018 Apr.
PubMed 29339395Taubert M, Luckermann M, Vente A, Dalhoff A, Fuhr U. Population Pharmacokinetics of Finafloxacin in Healthy Volunteers and Patients with Complicated Urinary Tract Infections. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02328-17. doi: 10.1128/AAC.02328-17. Print 2018 Apr.
PubMed 29339394Vente A, Bentley C, Luckermann M, Tambyah P, Dalhoff A. Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02325-17. doi: 10.1128/AAC.02325-17. Print 2018 Apr.
PubMed 29339393
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01928433
- Acronym / sponsor ID
- FINA-007
- Conditions
- Urinary Tract Infections, Acute Pyelonephritis
- Keywords
- Urinary Tract Infection, Pyelonephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- MerLion Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Aug 2013 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fluoroquinolones are frequently prescribed for complicated Urinary Tract Infections (cUTI) and pyelonephritis, due to their activity against cUTI pathogens and high levels of excretion in the urine following oral and i.v. administration. However, many currently prescribed fluoroquinolones exhibit reduced antibacterial activity at low pH, which suggests reduced activity in infected urinary tracts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Finafloxacin 5 days | Experimental | Drug: Finafloxacin 800 mg i.v. once daily, Drug: Finafloxacin 800 mg tablets once daily, Drug: Ciprofloxacin placebo i.v. twice daily, Drug: Ciprofloxacin placebo oral twice dailyIntervention: Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 5 days. |
| Finafloxacin 10 days | Experimental | Drug: Finafloxacin 800 mg i.v. once daily, Drug: Finafloxacin 800 mg tablets once daily, Drug: Ciprofloxacin placebo i.v. twice daily, Drug: Ciprofloxacin placebo oral twice dailyIntervention: Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 10 days. |
| Ciprofloxacin 10 days | Active comparator | Drug: Finafloxacin placebo i.v. once daily, Drug: Finafloxacin placebo tablets once daily, Drug: Ciprofloxacin 400 mg i.v. twice daily, Drug: Ciprofloxacin 500 mg oral twice dailyIntervention: Ciprofloxacin 400 mg i.v. twice daily and Finafloxacin placebo i.v. once daily Ciprofloxacin 500 mg oral twice daily and Finafloxacin placebo tablets once daily Ciprofloxacin (i.v. and oral) for a total of 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Be male or female subjects ≥ 18 years of age.
- If a female and
- If a male, should agree to use reliable birth control methods (contraception or other barrier device) during study participation.
- Must have complicated lower urinary tract infection or acute complicated or uncomplicated pyelonephritis (cPN or uPN; see section 5.3) and must have at least two of the following acute signs and symptoms
- Provide one pre-treatment adequate urine sample (the urine sample must return a positive culture in order for the subject to remain eligible for the study) For males: midstream clean catch, for females: in-out catheterisation or midstream clean catch. The urine sample must be provided within 24 hours before the start of administration of the first dose of study drug.
Key exclusion criteria (32 listed)
- Uncomplicated cystitis in females.
- Failed previous antibiotic treatment within the last 4 weeks due to culture confirmed fluoroquinolone resistant pathogens.
- Having ileal loops, urinary diversion with bowel segments or suspected or confirmed vesico-ureteral reflux, suspected or confirmed perinephric or intrarenal abscess (if an abscess is suspected an ultrasound should be performed to confirm and exclude).
- History of renal transplant any permanent complicating factors of the urinary tract (including complete obstruction, suspected or confirmed prostatitis or epididymitis) which cannot be effectively treated during the therapy of the infection.
- Indwelling urinary catheters expected to remain in place after therapy has been completed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finafloxacin 800 mg i.v. once dailyAlso: FinafloxacinInfused over 60 mins [i.v. pump]) for at least 3 days. | Drug | Finafloxacin 10 days, Finafloxacin 5 days |
| Finafloxacin placebo i.v. once dailyAlso: SalineInfused over 60 mins [i.v. pump]) for at least 3 days. | Drug | Ciprofloxacin 10 days |
| Finafloxacin 800 mg tablets once dailyAlso: FinafloxacinAdministered as four 200 mg tablets | Drug | Finafloxacin 10 days, Finafloxacin 5 days |
| Finafloxacin placebo tablets once dailyAdministered as four tablets | Drug | Ciprofloxacin 10 days |
| Ciprofloxacin 400 mg i.v. twice dailyAlso: Ciprofloxacin Kabi InfusionslösungInfused over approximately 60 mins [i.v. pump]) for at least 3 days | Drug | Ciprofloxacin 10 days |
| Ciprofloxacin placebo i.v. twice dailyAlso: SalineInfused over approximately 60 mins [i.v. pump]) for at least 3 days | Drug | Finafloxacin 10 days, Finafloxacin 5 days |
| Ciprofloxacin 500 mg oral twice dailyAlso: Ciprofloxacin real 250/500/750 mgAdministered as two 250 mg capsules. | Drug | Ciprofloxacin 10 days |
| Ciprofloxacin placebo oral twice dailyAdministered as two capsules. | Drug | Finafloxacin 10 days, Finafloxacin 5 days |
Primary outcome
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 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.
5 secondary outcomes
Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3).
Time frame: Day 3
Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10).
Time frame: Day 10
Number of Participants With Clinical and Microbiological Response at the End of Study (EoS) Visit (Day 24).
Time frame: Day 24
The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Treatment-emergent Adverse Events
Time frame: Screening to Day 24
The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Participants Who Discontinued Due to TEAE
Time frame: Screening to day 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29339395Wagenlehner F, Nowicki M, Bentley C, Luckermann M, Wohlert S, Fischer C, Vente A, Naber K, Dalhoff A. Explorative Randomized Phase II Clinical Study of the Efficacy and Safety of Finafloxacin versus Ciprofloxacin for Treatment of Complicated Urinary Tract Infections. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02317-17. doi: 10.1128/AAC.02317-17. Print 2018 Apr.
- Derived from this study: PubMed 29339394Taubert M, Luckermann M, Vente A, Dalhoff A, Fuhr U. Population Pharmacokinetics of Finafloxacin in Healthy Volunteers and Patients with Complicated Urinary Tract Infections. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02328-17. doi: 10.1128/AAC.02328-17. Print 2018 Apr.
- Derived from this study: PubMed 29339393Vente A, Bentley C, Luckermann M, Tambyah P, Dalhoff A. Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02325-17. doi: 10.1128/AAC.02325-17. Print 2018 Apr.
- Individual participant dataSharing planned: No
Related trials for Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Wagenlehner, Prof. principal investigator
Germany: University Hospital Giessen and Marburg, Department of Urology
Michal Nowicki, Prof. principal investigator
Poland: Medical University Lodz, Department of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finafloxacin 800 mg i.v. once daily, Finafloxacin 800 mg tablets once daily and Ciprofloxacin 400 mg i.v. twice daily in people with Urinary Tract Infections and Acute Pyelonephritis, run by MerLion Pharmaceuticals GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical and Microbiological Response (time frame: Day 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928433, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.