Urinary Tract Infections Clinical Trial
Official title:
Piperacillin/Tazobactam Versus Carbapenems in Non-bacteremic Urinary Tract Infections Due to Extended-spectrum β-lactamase (ESBL)-Producing Escherichia Coli or Klebsiella Pneumoniae - (CAPITIS Study)
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.
Urinary tract infection (UTI) is a common cause of hospitalization worldwide, the prevalence
throughout the life of UTI has been reported in about 50,000 cases per 100,000 women and
13,000 per 100,000 men in the United States. Hospitalization for community-acquired UTI is
about 33%. Furthermore, the UTI related to bladder catheterization during hospitalization is
the most common type of infection acquired, representing 40% of all nosocomial infections.
UTI hospitalization is associated with a high cost to the healthcare system.
The diagnosis of UTI is based on demonstrating the presence of bacteria urine in patients
with suggestive clinical manifestations and verifying the host's inflammatory response to
infection. The most common etiological agents include Escherichia coli, Klebsiella spp, and
Proteus spp, with different prevalence and antibiotic susceptibility profiles among different
populations.
Currently the appropriate treatment of UTI is a growing concern in the medical community
because Gram-negative, specifically Enterobacteriaceae, bacteria have acquired genes encoding
antibiotic resistance mechanisms. The β-lactamase spread spectrum (ESBL) are documented with
increasing frequency among microorganisms causing UTI. Current treatment options for ESBL
bacteria include nitrofurantoin, fosfomycin, piperacillin-tazobactam, carbapenems, and
aminoglycosides.
Carbapenems and piperacillin-tazobactam are antibiotics used in medical practice for many
years, both therapies are licensed for the treatment of non-bacteremic UTI; however, so far
there is not enough evidence to discriminate the best choice for the treatment of
non-bacteremic UTI (although carbapenems are considered drugs of choice for infections caused
by these microorganisms), but carbapenems use has been associated with an increased risk of
"collateral damage" related to the generation of resistant germs.
The investigators will compare between piperacillin/tazobactam and carbapenems the
effectiveness in achieving clinical cure for non-bacteremic UTI caused by ESBL
microorganisms. Researchers principal hypothesis is that Piperacillin/tazobactam is not
inferior to carbapenems in achieving clinical cure in the targeted treatment of UTI caused by
non-bacteremic due to E. coli or K. pneumoniae ESBL in adults requiring hospitalization.
Researchers will verify too if Piperacillin/Tazobactam is not associated with increased risk
of adverse events during the targeted treatment of non-bacteremic ITU caused by E. coli or K.
pneumoniae ESBL in adults requiring hospital admission, compared with Carbapenems therapy.
To perform the protocol researchers follows the recommendations for the design of trials
investigating treatment options for resistant bacteria multidrug (Uncomplicated Urinary Tract
Infections: Developing Drugs for Treatment) of the United States Agency for Food and Drug
Administration (FDA).
Participants will be included in the study with informed consent. The study variables will be
obtained by patient interview and review of medical history. Variables will be recorded in a
computerized database developed specifically for this study, with exclusive access for the
researchers.
The estimated project duration is 2 years expected to begin in april of 2019.
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