Patients presenting urinary tract infections due to Extended Spectrum Beta-Lactamases producing or AmpC hyperproducing Enterobacteriaceae. MedDRA version: 9.1 Level: LLT Classification code 10046571 Term: Urinary tract infection MedDRA version: 9.1 Level: LLT Classification code 10002737 Term: Antibiotic resistant strain
Conditions
Interventions
Trade Name: Negaban
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: TEMOCILLIN
CAS Number: 66148785
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Sponsors
Belpharma SA/NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • patient presenting a complicated urinary tract infection (i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign bodies, or urologic abnormalities) due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae susceptible to temocillin requiring parenteral antimicrobial therapy • community or hospital acquired infecting bacteria • signed informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • patients infected with a strain resistant to temocillin (if included at first, then the patient will be kept in the ITT group, therapy will be switched and the patient will be followed for the same time as other enrolled patients). • patients having received an active antimicrobial therapy during the 48h before the beginning of temocillin treatment (i.e. having received an antibiotic to which the infecting bacteria is susceptible) except temocillin (i.e. if the patient has been treated empirically with temocillin, they will not be excluded) • patients presenting with another site of infection than urinary (except onset of bacteremia from urinary tract origin) due to Gram negative bacteria • patients needing concomitant antimicrobial therapy with the exception of benzylpenicillin • uncomplicated cystitis • complete obstruction of the urinary tract • prostatitis • perinephretic or intrarenal abscesses • renal transplant • children (up to 18 years old) • pregnancy or lactation • chronically dialyzed patients • immunocompromising therapy or illness • known allergy to penicillin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Eradication rate in the Modified Intent To Treat population at the End Of Therapy;Main Objective: Demonstrate efficacy and safety of temocillin in urinary tract infections due to Extended Spectrum Beta-Lactamases producing or AmpC hyperproducing Enterobacteriaceae.;Secondary Objective: Monitor ESBL and AmpC faecal carriage (optional for the patients) and the incidence of Clostridium difficile infection in patients treated by temocillin | — |
Countries
United Kingdom
Outcome results
None listed