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Clinical Trials/EUCTR2013-002922-21-ES
EUCTR2013-002922-21-ES
Active, not recruiting
Phase 1

Randomized, phase III, multicentre, open-labelled clinical trial, to evaluate the efficacy of fosfomycin vs meropenem in the treatment of bacteremic urinary tract infection caused by Escherichia coli producing extended-spectrum beta-lactamases (ESBL).

FISEVI0 sites198 target enrollmentFebruary 18, 2014
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ConditionsBacteremic urinary tract infection by Escherichia coli extended spectrum beta-lactamase (ESBL).MedDRA version: 16.1 Level: PT Classification code 10052238 Term: Escherichia urinary tract infection System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsDisodium FosfomycinMeronem

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bacteremic urinary tract infection by Escherichia coli extended spectrum beta-lactamase (ESBL).
Sponsor
FISEVI
Enrollment
198
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 18, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
FISEVI

Eligibility Criteria

Inclusion Criteria

  • •\* Adult (over 18\) hospitalized patients diagnosed with bacteremia due to urinary tract infection by E. coli extended spectrum beta\-lactamase (ESBL).
  • •\*Isolation of this microorganism in blood culture with clinical sepsis without other obvious or the most likely origin of the urinary bacteremia.
  • •\*Required intravenous treatment during 5 days at least.
  • •\*Women of childbearing potential must have a negative pregnancy test.
  • •\*Signed informed consent form.
  • •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 180
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\*Polymicrobial bacteremia.
  • •\*Undrained renal abscess or not resolved urinary tract obstruction.
  • •\*Prostatitis.
  • •\*Haematogenous or contiguous urinary infection
  • •\*Concomitant infections
  • •\*Polycystic kidney disease.
  • •\*Renal trasplantation.
  • •\*Allergy or hypersensitivity to fosfomycin or meropenem.
  • •\*Terminal condition, or life expectancy less than 90 days, or palliative treatment of the underlying disease.
  • •\*Delayed inclusion \> 12 hours since the identification of E. coli ESBL in blood culture.

Outcomes

Primary Outcomes

Not specified

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