Acute Uncomplicated PyelonephritisPhase 4NCT00239161
Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin
A Phase 4 study testing Levofloxacin in people with Acute Uncomplicated Pyelonephritis, run by University of Manitoba at 4 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 using a shorter course of therapy to treat patients with infections of their kidney. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Uncomplicated Pyelonephritis
- What is being tested?
- Levofloxacin
- How many people
- 30 participants
- Where
- 4 sitesCanada
- Study dates
- Sep 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recent onset (less than 7 days) of costovertebral angle pain or tenderness with or without fever, and with or without lower urinary tract symptoms (dysuria, frequency, urgency). Diabetic women without long term complications of diabetes (retinopathy, nephropathy, or neuropathy) may be enrolled.
- Stable hemodynamic status and able to tolerate oral medication.
- Pretherapy urine culture >107 cfu/L (>104 cfu/ml) of a uropathogen (E. coli, other Enterobacteriaceae, S. saprophyticus). Patients will be enrolled into the study prior to urine culture results being known. If pretherapy cultures are subsequently not positive (usually at 48 hours), subjects will be discontinued.
- Pyuria (> 10 wbc/mm3 or > 10 X106 wbc/L by hemocytometer; > 6-10 wbc/hpf, or > 1+ LE (leukocyte esterase) dipstick).
Who cannot join
- ·Pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Misericordia Urgent Care
Winnipeg, Manitoba, R3C 1A2
University of Manitoba
Winnipeg, Manitoba, R3E 0W3
About this study
Official title: TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study
The purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin using a shorter course of therapy to treat patients with infections of their kidney.
Read the detailed description
The goal is to complete a pilot study of short course (5 days), high dose, levofloxacin treatment for women with acute uncomplicated pyelonephritis. Specific study objectives include:
- To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women.
- To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis.
- To identify urine proteins associated with the inflammatory response of acute pyelonephritis, and characterize the time course of resolution of these proteins following initiation of treatment.
- Conditions
- Acute Uncomplicated Pyelonephritis
- Being tested
- Levofloxacin
- Keywords
- Pyelonephritis
- Medical subject headings
- Pyelonephritis
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.
Microbiological cure at the 10-14 day and 33-35 day followup
Secondary outcomes (1)
Clinical outcome at each visit. Microbiologic outcomes at 24,48,and72 hrs, adverse antimicrobial effects, adverse events or antimicrobial resistance. Correlation between pharmacodynamic parameters, bacteriologic and clinical resolution will be analyzed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startSep 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 Acute Uncomplicated PyelonephritisStudies 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
- Collaborators
- Ortho-McNeil Pharmaceutical, Janssen-Ortho Inc., Canada, PriCara, Unit of Ortho-McNeil, Inc.
- Investigators
- Lindsay E Nicolle, MD, FRCPC, Principal investigator, University of ManitobaGodfrey KM Harding, MD, FRCPC, Principal investigator, University of ManitobaGeorge G Zhanel, PhD, FCCP, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239161
- Sponsor's protocol ID
- CAPSS-353
- Other IDs
- LOF-UTI-2
- Status last verified
- Aug 2005
- First submitted
- 12 Oct 2005
- Last updated
- 14 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT OF ACUTE UNCOMPLICATED PYELONEPHRITIS WITH SHORT COURSE LEVOFLOXACIN A Pilot Study
- ClinicalTrials.gov ID
- NCT00239161
- Acronym / sponsor ID
- CAPSS-353
- Conditions
- Acute Uncomplicated Pyelonephritis
- Keywords
- Pyelonephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Ortho-McNeil Pharmaceutical, Janssen-Ortho Inc., Canada, PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Sep 2004
- Study completion
- Jul 2005
- First posted
- 14 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 using a shorter course of therapy to treat patients with infections of their kidney.
Detailed description
The goal is to complete a pilot study of short course (5 days), high dose, levofloxacin treatment for women with acute uncomplicated pyelonephritis. Specific study objectives include:
- To assess the efficacy and tolerability of levofloxacin 750 mg once daily for treatment of acute uncomplicated pyelonephritis in 25 women.
- To describe the population pharmacokinetics of levofloxacin 750 mg once daily in treatment of young women with acute pyelonephritis.
- To identify urine proteins associated with the inflammatory response of acute pyelonephritis, and characterize the time course of resolution of these proteins following initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Recent onset (less than 7 days) of costovertebral angle pain or tenderness with or without fever, and with or without lower urinary tract symptoms (dysuria, frequency, urgency). Diabetic women without long term complications of diabetes (retinopathy, nephropathy, or neuropathy) may be enrolled.
- Stable hemodynamic status and able to tolerate oral medication.
- Pretherapy urine culture >107 cfu/L (>104 cfu/ml) of a uropathogen (E. coli, other Enterobacteriaceae, S. saprophyticus). Patients will be enrolled into the study prior to urine culture results being known. If pretherapy cultures are subsequently not positive (usually at 48 hours), subjects will be discontinued.
- Pyuria (> 10 wbc/mm3 or > 10 X106 wbc/L by hemocytometer; > 6-10 wbc/hpf, or > 1+ LE (leukocyte esterase) dipstick).
Key exclusion criteria (1 listed)
- ·Pregnancy, breastfeeding, fluoroquinolone allergy, and any underlying structural or functional genitourinary abnormality.
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
Microbiological cure at the 10-14 day and 33-35 day followup
1 secondary outcome
Clinical outcome at each visit. Microbiologic outcomes at 24,48,and72 hrs, adverse antimicrobial effects, adverse events or antimicrobial resistance. Correlation between pharmacodynamic parameters, bacteriologic and clinical resolution will be analyzed.
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 14 Oct 2005.
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 KM Harding, MD, FRCPC principal investigator
University of Manitoba
George G Zhanel, PhD, FCCP principal investigator
University of Manitoba
4 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 Acute Uncomplicated Pyelonephritis, run by University of Manitoba at 4 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 4 inclusion and 1 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 14 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Microbiological cure at the 10-14 day and 33-35 day followup. 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 14 Oct 2005.