Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic UTI Due to -ESBL-producing Enterobacteriaceae

• Status: Unknown status
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy in achieving clinical cure in non-bacteremic urinary tract infections (UTI) caused by Escherichia coli or Klebsiella pneumoniae producers of extended-spectrum β-lactamases (ESBL) in adult patients. Half of participants will receive Piperacillin/Tazobactam as treatment, while the other half will receive Carbapenems.

The investigators will verify that Piperacillin/Tazobactam is not inferior in achieving clinical cure, and that is not associated with a higher risk of adverse events in the directed treatment of non-bacteremic UTI compared to Carbapenems.

The researchers hope to improve the use of antibiotics in the non-bacteremic UTI, reducing the "collateral damage" related to a deterioration in the prognosis of patients and the generation of resistant germs caused by the use of broad-spectrum antibiotics as carbapenems.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad del Norte
• Treatments: Ertapenem; Meropenem; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Inclusion Criteria:

• Adults (≥18 years) with hospital admission for non-bacteremic UTI caused by E. coli or K. pneumoniae ESBL susceptible to piperacillin/tazobactam and carbapenems.

• Presence of any risk factor associated with UTI due to ESBL germs: older age 64 years, diabetes mellitus, bladder catheter, previous antibiotics in the last 6 months, hospitalization in the last 6 months, urological surgery in the last 30 days, infections recurrent urinary.

• Diagnosis of UTI confirmed by: 1) fever, 2) urine culture> 100000 CFU with isolation E. coli or K. pneumoniae ESBL susceptible to piperacillin / tazobactam and carbapenems, and 3) lumbar and / or abdominal pain with or without low urinary symptoms (dysuria, tenesmus, urgency), and 4) no other cause that explains the patient's symptoms

• Signed informed consent.

• Negative pregnancy test in fertile women.

Exclusion Criteria:

• Non-acceptance of participation in the study.

• Pregnancy.

• Hypersensitivity and/or previous intolerance to penicillins, piperacillin/tazobactam or carbapenems.

• Bacteremia, hematogenous infection or other concomitant infection.

• Immunosuppression.

• In case of obstructive uropathy, lack of early surgical resolution.

• Evidence of acute or chronic prostatitis.

• Renal abscess

• Polycystic disease in the kidneys.

• Palliative care or life expectancy <90 days.

• Heart failure (NYHA) functional class III or IV.

• Liver cirrhosis.

• Renal insufficiency in dialysis treatment.

• Empirical active treatment against bacteria isolated by urine cultures other than E. coli or K. pneumoniae BLEE.

• Participation in another clinical trial for infections.

• Hypersensitivity to amide-type local anesthetics.