SuspendedPhase 4

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

Stopped: Low admission of patients with the condition to the hospital because it is a reference center for care of the SARS-CoV-2 pandemic

Colombia198 participantsStarted 2019-04-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 tr…

What they're measuring

Clinical cure.

Timeframe: At 5-7 day after the end of treatment (cure test), or for early response after 5 days from the start of treatment.

Trial details

NCT IDNCT03891433

SponsorUniversidad del Norte

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01