Complicated Urinary InfectionPhase 4NCT00245791
Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time
A Phase 4 study testing Levofloxacin in people with Complicated Urinary Infection, run by University of Manitoba at 3 sites in Canada.
Trial summary
The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin and using a shorter course of therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Complicated Urinary Infection
- What is being tested?
- Levofloxacin
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2004to Jul 2005
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acute symptoms of urinary infection of less than 7 days duration and an underlying structural or functional abnormality of the genitourinary tract.
- Pre-therapy urine culture > 105 cfu/ml (> 108 cfu/L) of at least one urinary pathogen.
- Age 18-80 years, male or female.
Who cannot join
- Prior allergic reaction to any fluoroquinolone antimicrobial.
- Known infection with a fluoroquinolone - resistant organism.
- Requiring parenteral therapy because of severity of illness or unable to take oral medications.
- Women who are pregnant or breastfeeding.
- Requiring additional antimicrobial therapy for infections elsewhere.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
University of Manitoba
Winnipeg, Manitoba, R3E 0W3
About this study
Official title: TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN
The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin and using a shorter course of therapy.
Read the detailed description
This study will be a pilot study of the efficacy of 750 mg of levofloxacin once daily for 5 days in the treatment of complicated urinary tract infection.
The specific objectives include:
- To describe clinical and microbiological outcome at short and long term follow-up with 5 days levofloxacin in subjects with acute symptomatic complicated urinary infection, both with and without indwelling catheters.
- To determine the tolerability of levofloxacin 750-mg once daily in patients with complicated urinary infection.
- To describe some characteristics of the resolution of the inflammatory response with treatment of complicated urinary infection as demonstrated by changes in urine proteins.
- To identify any emergence of resistant organisms in recurrent urinary infection following therapy.
- Conditions
- Complicated Urinary Infection
- Being tested
- Levofloxacin
- Keywords
- Complicated Urinary Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
Secondary outcomes (1)
Variables will include outcomes at 2 days of therapy, failure to complete therapy, adverse drug effects, long term clinical and microbiologic outcomes, and emergence of resistant organisms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startOct 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary InfectionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Lindsay E Nicolle, MD, FRCPC, Principal investigator, University of ManitobaGodfrey KP Harding, MD, FRCPC, Principal investigator, University of ManitobaGeorge G Zhanel, PhD, FCCP, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245791
- Sponsor's protocol ID
- CAPSS-383
- Other IDs
- LOF-UTI-3
- Status last verified
- Aug 2005
- First submitted
- 27 Oct 2005
- Last updated
- 3 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT OF COMPLICATED URINARY INFECTION WITH FIVE DAY HIGH DOSE LEVOFLOXACIN
- ClinicalTrials.gov ID
- NCT00245791
- Acronym / sponsor ID
- CAPSS-383
- Conditions
- Complicated Urinary Infection
- Keywords
- Complicated Urinary Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Jul 2005
- First posted
- 28 Oct 2005 (estimated)
- 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.
The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin and using a shorter course of therapy.
Detailed description
This study will be a pilot study of the efficacy of 750 mg of levofloxacin once daily for 5 days in the treatment of complicated urinary tract infection.
The specific objectives include:
- To describe clinical and microbiological outcome at short and long term follow-up with 5 days levofloxacin in subjects with acute symptomatic complicated urinary infection, both with and without indwelling catheters.
- To determine the tolerability of levofloxacin 750-mg once daily in patients with complicated urinary infection.
- To describe some characteristics of the resolution of the inflammatory response with treatment of complicated urinary infection as demonstrated by changes in urine proteins.
- To identify any emergence of resistant organisms in recurrent urinary infection following therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute symptoms of urinary infection of less than 7 days duration and an underlying structural or functional abnormality of the genitourinary tract.
- Pre-therapy urine culture > 105 cfu/ml (> 108 cfu/L) of at least one urinary pathogen.
- Age 18-80 years, male or female.
Key exclusion criteria (5 listed)
- Prior allergic reaction to any fluoroquinolone antimicrobial.
- Known infection with a fluoroquinolone - resistant organism.
- Requiring parenteral therapy because of severity of illness or unable to take oral medications.
- Women who are pregnant or breastfeeding.
- Requiring additional antimicrobial therapy for infections elsewhere.
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 |
|---|---|---|
| Levofloxacin | Drug | – |
Primary outcome
Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).
1 secondary outcome
Variables will include outcomes at 2 days of therapy, failure to complete therapy, adverse drug effects, long term clinical and microbiologic outcomes, and emergence of resistant organisms.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Lindsay E Nicolle, MD, FRCPC principal investigator
University of Manitoba
Godfrey KP Harding, MD, FRCPC principal investigator
University of Manitoba
George G Zhanel, PhD, FCCP principal investigator
University of Manitoba
3 sites 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 Complicated Urinary Infection, run by University of Manitoba at 3 sites in Canada.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The study was stopped early. Results are not available in the source record.
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?
Microbiologic and clinical cure at the early post-therapy follow-up visit (12-19 days after initiating antimicrobial).. 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 3 Jun 2015.