Antimicrobial resistance is a major global problem, particularly in hospital-acquired infections (HAIs). Gram-negative bacilli (GNB), including Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, are among the most common pathogens associated with multidrug resistance and HAIs. These bacteria are of special concern because few therapeutic options are available. Traditionally, the duration of treatment for severe multidrug-resistant (MDR)-GNB infections is 14 days. Studies of severe infections by GNB, regardless of susceptibility profile, have shown that shorter antimicrobial treatments are not inferior to traditional durations of therapy and are associated with a lower incidence of adverse effects. However, there are currently no studies assessing whether shorter duration of antimicrobial treatment is effective for MDR-GNB. This open-label, randomized clinical trial aims to assess the non-inferiority of 7-day antibiotic therapy compared to conventional 14-day treatment in severe infections by MDR-GNB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
In experimental group patients with severe infection caused by MDR-GNB and who present a clinical response on day 7 (±1) of adequate antimicrobial therapy, the therapy will be suspended. The active control group will continue therapy until day 14 (±1).
Hospital OTO clinica
Fortaleza, Ceará, Brazil
Hospital Evangélico de Vila Velha
Vila Velha, Espírito Santo, Brazil
Hospital Cleriston de Andrade
Feira de Santana, Estado de Bahia, Brazil
Hospital Couto Maia
Salvador, Estado de Bahia, Brazil
Hospital da Cidade
Salvador, Estado de Bahia, Brazil
Clinical failure
Incidence of clinical failure. Clinical failure is a composite outcome defined by the presence of one of the following: Infection relapse (infection anywhere in the body by the same MDR-GNB) or Death
Time frame: 28 days after randomization
Days alive and free from hospitalization
Number of days in which patients are alive and out of the hospital
Time frame: 28 days after randomization
Days alive and free from any antibiotic therapy
Number of days in which patients are alive and free from any antibiotic therapy
Time frame: 28 days after randomization
Occurrence of infections caused by other MRD-GNB or other bacteria
Incidence of infections caused by other MRD-GNB or other bacteria
Time frame: 28 days after randomization
Length of intensive care unit stay
Number of days in which patients stayed at intensive care unit
Time frame: 28 days after randomization
Acute kidney injury
Incidence of acute kidney injury, according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Time frame: 28 days after randomization
Diarrhea for any cause
Incidence of any diarrhea. Diarrhea is defined as 3 or more episodes per day.
Time frame: 28 days after randomization
Confirmed infection by Clostridioides difficile
Incidence of Clostridioides difficile infection
Time frame: 28 days after randomization
Hemodynamic instability lasting more than 6 hours
Incidence of hemodynamic instability lasting more than 6 hours. Hemodynamic instability is defined as hypotension that requires the use of doses of dopamine above 15 mcg/kg/min, epinephrine above 0.1 mcg/kg/min, or norepinephrine above 0.1 mcg/kg/min
Time frame: 14 days after randomization
Other adverse events related to antimicrobial therapy
Incidence of any other adverse event related to antimicrobial therapy
Time frame: 28 days after randomization
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Instituto Hospital de Base do Distrito Federal
Brasília, Federal District, Brazil
Hospital Universitário de Brasília
Brasília, Federal District, Brazil
Hospital Presidente Vargas
São Luís, Maranhão, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Hospital Vila da Serra (Instituto Materno Infantil de Minas Gerais S/A)
Nova Lima, Minas Gerais, Brazil
...and 19 more locations