Randomized controlled trial of the efficacy of fosfomycin vs ciprofloxacin as antibiotic prophylaxis before transrectal ultrasound guided prostate

• Conditions: urinary sepsis; Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

• Registration Number: EUCTR2012-001031-31-ES
• Lead Sponsor: Fundación para Formación e Investigación Sanitaria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

? Age over 18 years.
? A patient who attends hospital outpatient biopsy protática by PSA over 4 ng / ml or suspicious digital rectal tumor.
? Subjects who have given written informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

? History (confirmed or suspected) allergy to any of the drugs included in the study.
? History (confirmed or suspected) of intolerance to any of the drugs included in the study.
? Presence of urinary tract infection confirmed by urine culture or urinalysis.
? Clinical findings suggestive of infection (any origin).
? Antibiotic therapy in the last 4 weeks.
? Patient carrier catheter.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified