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

NCT03891433 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-12-06

No results posted yet for this study

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.

Conditions

  • Urinary Tract Infections
  • Enterobacteriaceae Infections
  • Infection Due to ESBL Bacteria
  • Carbapenem
  • Escherichia Coli Infection
  • Klebsiella Pneumoniae Infection
  • Clinical Trial
  • Drug Resistance, Bacterial

Interventions

DRUG

Meropenem

Carbapenems group intervention.

DRUG

Ertapenem 1000 MG

Carbapenems group intervention.

DRUG

Piperacillin, Tazobactam 4-0.5G Solution for Injection

Piperacillin/Tazobactam group intervention.

Sponsors & Collaborators

  • Universidad del Norte

    lead OTHER

Principal Investigators

  • Diego F Viasus Perez, MD. PhD. · Universidad del Norte´s Hospital-Infectious Diseases.

  • Andres F Estupinan Bohorquez, MD · Universidad del Norte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2024-12-01
Completion
2026-04-01

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891433 on ClinicalTrials.gov