Cefuroxime Resistance in Pyelonephritis

NCT04616352 | Completed

• 1 other identifier: ivucef001
• Study Type: observational
• Target: 973
• Locations: 1 country
• Sites: 1

Brief Summary

Resistance to empirical antibiotic treatment has resulted in increased mortality and morbidity in serious infections caused by certain common resistant pathogens in the community. The risk for increased mortality has been also the motivation for recent guidelines that suggest early empirical antimicrobial treatment with broad spectrum antibiotics within a few hours of suspecting sepsis, regardless of the potential microorganism or infection focus. Resistance to second-generation cephalosporins among patients with community-acquired urinary tract infection by E. coli has exceeded 20% in an increasing number of institutions and communities, without being clear about the impact of such resistance on the effectiveness of treatment. This is especially important in urinary infections, since, in general, mortality is very low. We expect to establish if there is a relationship between inappropriate empirical therapy and morbidity (in terms of length of stay or readmission) among hospitalized patients with pyelonephritis treated with empirical cefuroxime therapy to help to define the need for a change in the current guidelines. These guidelines will have application not only in Colombia, but also in other countries in Latin America or other countries that still use this empirical therapy. It will also define the need for use of broader spectrum antibiotics in this clinical scenario.

Conditions

Urinary Tract Infections

Keywords

pyelonephritis; urinary tract infections, complicated; cefuroxime; cephalosporins; Escherichia coli; Drug Resistance, Microbial

Outcome Measures

Primary Outcomes (3)

• Time to hospital discharge

  Time since admission to hospital discharge

  Up to 30 days

• Readmission

  Proportion of patients admitted to hospital because of new episode of urinary tract infection

  Up to 30 days after discharge

• Time to readmission

  Time since discharge to readmission

  Up to 30 days after discharge

Interventions

Resistance to cefuroxime OTHER

Non susceptibility in vitro testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patiens with ≥ 18 years with a clinical diagnosis of community acquired pyelonephritis that require hospitalization and with positive culture for Escherichia coli.

You may qualify if:

• Age ≥ 18 years.
• Clinical diagnosis of pyelonephritis.
• Antibiotic treatment with cefuroxime.
• Urine culture positive for Escherichia coli

You may not qualify if:

• Use of antibiotic for less than 24 hours.
• Not availability of antimicrobial susceptibility testing.
• Use of urinary catheter for more than 30 days.

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Clínica Reina Sofía

Bogotá, DC, 111134, Colombia

Location

Related Publications (2)

• Nocua-Baez LC, Cortes JA, Leal AL, Arias GF, Ovalle-Guerro MV, Saavedra-Rojas SY, Buitrago G, Escobar-Perez JA, Castro-Cardozo B. [Antimicrobial susceptibility profile in urinary pathogens causing community-acquired infections in diabetic patients in Colombia]. Biomedica. 2017 Sep 1;37(3):353-360. doi: 10.7705/biomedica.v37i3.3348. Spanish.

  PMID: 28968012 BACKGROUND

• Leal AL, Cortes JA, Arias G, Ovalle MV, Saavedra SY, Buitrago G, Escobar JA, Castro BE; GREBO. [Emergence of resistance to third generation cephalosporins by Enterobacteriaceae causing community-onset urinary tract infections in hospitals in Colombia]. Enferm Infecc Microbiol Clin. 2013 May;31(5):298-303. doi: 10.1016/j.eimc.2012.04.007. Epub 2012 Jun 15. Spanish.

  PMID: 22703702 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections; Pyelonephritis; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis, Interstitial; Nephritis; Kidney Diseases; Pyelitis; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Jorge A Cortes, MD

  Univesidad Nacional de Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: November 4, 2020
• Study Start: December 26, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 30, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)