Urinary Tract InfectionPhase 2NCT01231737
Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)
A Phase 2 study testing prulifloxacin in people with Urinary Tract Infection, run by University Of Perugia.
Trial summary
Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- prulifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Feb 2012
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- Age over 18 years old
- No allergies to the drugs to be prescribed
- No counter-indications to this drug therapy
- Urine culture shows responsiveness to drugs at recruitment of patient
- History of urinary tract infections with at least three episodes in the previous year or two in the past six months
Who cannot join
- Lack of tolerability of prescribed drugs
About this study
Official title: Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection
Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist appointments, laboratory and instrumental tests and prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been proposed, doubts persist about the most efficacious pharmacological agents, duration of prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is suspended.
Aims of the study:
Read more
- To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):
- in reducing the number of urinary tract infection episodes during prophylaxis
- in reducing the number of urinary tract infection episodes after prophylaxis
- in improving the patient's quality of life .
- To assess :
- Tolerability of antibiotic prophylaxis
- The incidence of resistance to antibiotic therapy
- Conditions
- Urinary Tract Infection
- Being tested
- prulifloxacin
- Keywords
- Prophylasy, recurrent urinary tract infection, prulifloxacin, phosphomycin
- 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.
prulifloxacinDrug
Prulifloxacin 1 tablet/week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Prulifloxacin | Active comparator | Not described Receives: Drug: prulifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of urinary tract infection episodes during prophylaxis
Measured: 3 months
Secondary outcomes (1)
improving the patient's quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2012 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Investigators
- Elisabetta Costantini, Study chair, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231737
- Sponsor's protocol ID
- 002
- Status last verified
- Oct 2009
- First submitted
- 14 Jan 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT01231737
- Acronym / sponsor ID
- 002
- Conditions
- Urinary Tract Infection
- Keywords
- Prophylasy, recurrent urinary tract infection, prulifloxacin, phosphomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 1 Nov 2010 (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.
Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist appointments, laboratory and instrumental tests and prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been proposed, doubts persist about the most efficacious pharmacological agents, duration of prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is suspended.
Aims of the study:
- To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin):
- in reducing the number of urinary tract infection episodes during prophylaxis
- in reducing the number of urinary tract infection episodes after prophylaxis
- in improving the patient's quality of life .
- To assess :
- Tolerability of antibiotic prophylaxis
- The incidence of resistance to antibiotic therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prulifloxacin | Active comparator | Drug: prulifloxacin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients
- Age over 18 years old
- No allergies to the drugs to be prescribed
- No counter-indications to this drug therapy
- Urine culture shows responsiveness to drugs at recruitment of patient
Key exclusion criteria (1 listed)
- Lack of tolerability of prescribed drugs
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 |
|---|---|---|
| prulifloxacinPrulifloxacin 1 tablet/week for 12 weeks. | Drug | Prulifloxacin |
Primary outcome
number of urinary tract infection episodes during prophylaxis
Time frame: 3 months
1 secondary outcome
improving the patient's quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
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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.
Elisabetta Costantini study chair
University Of Perugia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing prulifloxacin in people with Urinary Tract Infection, run by University Of Perugia.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
number of urinary tract infection episodes during prophylaxis (time frame: 3 months). 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 1 Nov 2010.