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Clinical Trials/EUCTR2012-001031-31-ES
EUCTR2012-001031-31-ES
Active, not recruiting
Not Applicable

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

Fundación para Formación e Investigación Sanitaria0 sitesApril 17, 2012
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Conditionsurinary sepsisTherapeutic area: Body processes [G] - Microbiological Phenomena [G06]
DrugsMONUROL 3 gCETRAXAL 500 mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
urinary sepsis
Sponsor
Fundación para Formación e Investigación Sanitaria
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 17, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Fundación para Formación e Investigación Sanitaria

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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