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Status unknownNCT01231737Updated Nov 1, 2010

Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

A Phase 2 interventional study of prulifloxacin in Urinary Tract Infection, sponsored by University Of Perugia. Status unknown. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-11-01.

Sponsored by University Of Perugia · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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 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:

  1. 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 .
  2. To assess :

    • Tolerability of antibiotic prophylaxis
    • The incidence of resistance to antibiotic therapy
02

Conditions studied

  • Urinary Tract Infection

Keywords

  • Prophylasy
  • recurrent urinary tract infection
  • prulifloxacin
  • phosphomycin
03

In context

Urinary Tract Infections

779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.

This study's planned enrollment of 96 is below the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

University Of Perugia is the lead sponsor of 54 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Lack of tolerability of prescribed drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (estimated)

Study arms

  • Active comparator
    Prulifloxacin

    Drug: prulifloxacin

Interventions

06

What researchers measure

Primary outcomes

  1. number of urinary tract infection episodes during prophylaxis

    Time frame: 3 months

Secondary outcomes

  1. improving the patient's quality of life

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2010, a primary completion of Feb 2011 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2010
First posted
Nov 1, 2010
Start
Nov 2010
Primary completionEst.
Feb 2011
CompletionEst.
Feb 2012
Last update
Nov 1, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01231737
Lead sponsor
University Of Perugia
First posted
Nov 1, 2010
Start date
Nov 2010
Primary completion
Feb 2011 (estimated)
Completion
Feb 2012 (estimated)
Last update
Nov 1, 2010

Study contacts

Elisabetta Costantini
study chair · University Of Perugia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Prulifloxacin

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