Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

NCT01231737 | Unknown Phase 2 DMC

• 1 other identifier: 002
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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:

• 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

Keywords

Prophylasy; recurrent urinary tract infection; prulifloxacin; phosphomycin

Outcome Measures

Primary Outcomes (1)

• number of urinary tract infection episodes during prophylaxis

  3 months

Secondary Outcomes (1)

• improving the patient's quality of life

  1 year

Study Arms (1)

Prulifloxacin

ACTIVE COMPARATOR

Drug: prulifloxacin

Interventions

prulifloxacin DRUG

Prulifloxacin 1 tablet/week for 12 weeks.

Prulifloxacin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lack of tolerability of prescribed drugs

Sponsors & Collaborators

• University Of Perugia: lead

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

prulifloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Elisabetta Costantini

  University Of Perugia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: November 1, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2012
• Last Updated: November 1, 2010

Record last verified: 2009-10