Status:
TERMINATED
Efficacy and Pharmacokinetic/Pharmacodynamic Parameters of Cefoxitin in Women With Acute Pyelonephritis Without Severity Symptoms Due to Extended-spectrum β-lactamase Producing Escherichia Coli
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Pyelonephritis Without Severity Symptoms Due to ESBL-producing E.Coli
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Escherichia coli is the primary cause of urinary tract infections and Gram-negative bacteremia worldwide. Since the early years of the 21st century, E.coli has acquired a new mechanism of resistance t...
Detailed Description
Clinical Study: This is a prospective, multicentric, non-comparative, proof of concept study evaluating the efficacy of cefoxitin in women with acute ESBL-producing E. coli pyelonephritis without sev...
Eligibility Criteria
Inclusion
- Acute pyelonephritis without severity symptoms with a positive urine culture for ESBL-producing E. coli (cefoxitin-sensitive); antibiotic treatment should have been prescribed before inclusion for the empirical treatment of pyelonephritis, providing it is not active in vitro against ESBL-producing E. coli strain.
- Presenting at least a functional sign of urinary infection (dysuria, cloudy urine, pain on urination, pelvic or lumbar pain)
- Temperature \>38 ° or \< 36° during the infectious episode
- Imaging of the urinary ways realized within (echography) 72 hours preceding the inclusion.
Exclusion
- Pregnant women
- β-lactam allergy;
- antimicrobial therapy active in vitro against ESBL-producing E.coli pyelonephritis instituted prior to enrolment;
- life expectancy \<30 days;
- creatinine clearance \<30 ml/min;
- patient under guardianship or without healthcare coverage.
- Sign of sepsis severe or septic shock
- Major cognitive confusions
- Patients having refused to give her consent form in writing
- Not membership in a national insurance scheme or in the Universal Health Coverage (CMU).
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01820793
Start Date
May 1 2013
End Date
November 1 2015
Last Update
January 12 2018
Active Locations (1)
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1
Agnès LEFORT
Clichy, France, 92110