Urinary Tract InfectionPhase 4Levolet-KZ16NCT03160807
Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
A Phase 4 study testing Levofloxacin in people with Urinary Tract Infection, run by Dr. Reddy's Laboratories Limited at 1 site in Kazakhstan.
Trial summary
Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteKazakhstan
- Study dates
- 15 Apr 2017to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or non-pregnant women over 18 years of age with cUTI in
- One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
- One or more of the following underlying conditions suggestive of cUTI:
- Indwelling urinary catheter.
- Neurogenic bladder.
- Obstructive uropathy due to lithiasis, tumor or fibrosis.
- Acute urinary retention in men
Who cannot join
- History of allergy to quinolones
- Are unable to take oral medication
- Have an intractable infection requiring > 14 days of therapy
- Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
- Have prostatitis or epididymitis
- Have had a renal transplant
Show all 11Show fewer
- Have ileal loop or vesica- urethral reflux
- Have significant liver or kidney impairment
- Have a history of tendinopathy associated with fluoroquinolones
- Are pregnant, nursing
- Have a history of convulsions or CNS disorders
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,
Almaty, 050060
Ilyas Tungiskhanovich, +7727 337 8492, 22iliyas@mail.ru
About this study
Official title: An Open Label Non Placebo Study to Evaluate Efficacy and Safety of Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI
Read the detailed description
A complicated urinary tract infection is a urinary infection occurring in a patient with a structural or functional abnormality of the genitourinary tract.
Fluoroquinolones have been recommended as the antimicrobials of choice for the empirical treatment of complicated urinary tract. Levofloxacin is a broad spectrum agent, which is known to demonstrate good clinical efficacy against urinary tract infection (UTI).
There is no published evidence available on the empirical use of Levofloxacin 500 mg OD and its optimal duration of therapy in patients with Complicated Urinary Tract Infections (cUTI). The present study evaluates the efficacy and safety, and optimal duration of therapy of levofloxacin 500 mg OD in patients with complicated UTI.
- Conditions
- Urinary Tract Infection
- Being tested
- Levofloxacin
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called Levolet 500
Levolet 500 mg OD for 5 days
LevofloxacinDrug
Also called Levolet 500
Levolet 500 OD for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin 5 days | Experimental | Levolet 500 mg given for 5 days Receives: Drug: Levofloxacin |
| Levofloxacin 10 days | Active comparator | Levolet 500 mg given for 10 days Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical cure rates at test of cure visit (TOC) defined as follows- Cure: a complete resolution of clinically significant signs & symptoms
Cure: a complete resolution of clinically significant signs \& symptoms
Measured: Baseline to 5 days
Secondary outcomes (4)
Percentage of patients with microbiological eradication at test of cure visit (TOC)
Eradication: All uropathogens present at ≥105 CFU/ml at baseline had been reduced to <104 CFU/ml
Measured: Baseline to 5 days and upto 10 days
No. of adverse events in entire study duration
Type and total number of AEs recorded in study duration
Measured: Baseline to EOT visit (Baseline to 15 days)
Percentage of patient compliant to therapy in each study arm.
Percentage of patients compliant to study treatment
Measured: Baseline to EOT visit (Baseline to 15 days)
Percentage of patient samples sensitive to levofloxacin in each study arm.
Percent sensitivity
Measured: Baseline to EOT (Baseline to 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start15 Apr 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Ilyas Tungiskhanovich, Principal investigator, Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160807
- Sponsor's protocol ID
- EM_KZ_LEVOLET
- Acronym
- Levolet-KZ16
- Status last verified
- May 2017
- First submitted
- 28 Jun 2016
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Non Placebo Study to Evaluate Efficacy and Safety of Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT03160807
- Acronym / sponsor ID
- Levolet-KZ16 / EM_KZ_LEVOLET
- Conditions
- Urinary Tract Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI
Detailed description
A complicated urinary tract infection is a urinary infection occurring in a patient with a structural or functional abnormality of the genitourinary tract.
Fluoroquinolones have been recommended as the antimicrobials of choice for the empirical treatment of complicated urinary tract. Levofloxacin is a broad spectrum agent, which is known to demonstrate good clinical efficacy against urinary tract infection (UTI).
There is no published evidence available on the empirical use of Levofloxacin 500 mg OD and its optimal duration of therapy in patients with Complicated Urinary Tract Infections (cUTI). The present study evaluates the efficacy and safety, and optimal duration of therapy of levofloxacin 500 mg OD in patients with complicated UTI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin 5 days | Experimental | Drug: LevofloxacinLevolet 500 mg given for 5 days |
| Levofloxacin 10 days | Active comparator | Drug: LevofloxacinLevolet 500 mg given for 10 days |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or non-pregnant women over 18 years of age with cUTI in
- One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
- One or more of the following underlying conditions suggestive of cUTI:
- Indwelling urinary catheter.
- Neurogenic bladder.
Key exclusion criteria (11 listed)
- History of allergy to quinolones
- Are unable to take oral medication
- Have an intractable infection requiring > 14 days of therapy
- Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
- Have prostatitis or epididymitis
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 |
|---|---|---|
| LevofloxacinAlso: Levolet 500Levolet 500 mg OD for 5 days | Drug | Levofloxacin 5 days |
| LevofloxacinAlso: Levolet 500Levolet 500 OD for 10 days | Drug | Levofloxacin 10 days |
Primary outcome
Percentage of patients with clinical cure rates at test of cure visit (TOC) defined as follows- Cure: a complete resolution of clinically significant signs & symptoms
Time frame: Baseline to 5 days
Cure: a complete resolution of clinically significant signs \& symptoms
4 secondary outcomes
Percentage of patients with microbiological eradication at test of cure visit (TOC)
Time frame: Baseline to 5 days and upto 10 days
No. of adverse events in entire study duration
Time frame: Baseline to EOT visit (Baseline to 15 days)
Percentage of patient compliant to therapy in each study arm.
Time frame: Baseline to EOT visit (Baseline to 15 days)
Percentage of patient samples sensitive to levofloxacin in each study arm.
Time frame: Baseline to EOT (Baseline to 15 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: Yes
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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.
Dr Ilyas Tungiskhanovich principal investigator
Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levofloxacin in people with Urinary Tract Infection, run by Dr. Reddy's Laboratories Limited at 1 site in Kazakhstan.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 May 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 Kazakhstan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SUHAS S KHANDARKAR (04049002419 ext. 2419, suhassk@drreddys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with clinical cure rates at test of cure visit (TOC) defined as follows- Cure: a complete resolution of clinically significant signs & symptoms (time frame: Baseline to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2017.