Clinical Trial: Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized, Multicenter, Phase III, Controlled Clinical Trial, to Demonstrate the no Inferiority of Reduced Antibiotic Treatment vs a Broad Spectrum Betalactam Antipseudomonal Treatment in Patients Wi

Brief Summary:

The continuous increase in the bacterial resistance rate and the slow arrival of new therapeutic options have turned into an antibiotic crisis. One of the strategies proposed by stewardship programs to try to change this situation described worldwide is the use of antibiotics with the lowest possible antimicrobial spectrum.

Enterobacteriaceae bacteremia is a good example of how this strategy would be applied. The empirical treatment of nosocomial bacteremia by Enterobacteriaceae comprises in several cases one or two antibiotics with antipseudomonal activity, being much less common than desirable a subsequent change to narrower spectrum antibiotics based on susceptibility data ("de escalation"). This is because the safety of de escalation is based only on expert advice and some observational studies, so their efficacy and safety is questioned by many clinicians and therefore its use is lower than desired. In fact, a recent systematic review of the Cochrane Library concluded that randomized studies to support this practice are needed. Investigators propose a "real clinical practice-based" randomized trial to compare the efficacy and safety of continuing with an antipseudomonal agents vs. de-escalation according to a pre-specified rule, in patients with bacteraemia due to Enterobacteriaceae.


Detailed Summary:
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Current Primary Outcome: Clinical cure at day 3-5 after treatment. [ Time Frame: Day 3-5 after end of treatment ]

Clinical cure: complete resolution of infection symptoms (bacteremia) present at the day on which the assessment is done and patient is alive.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Early clinical and microbiological response. [ Time Frame: After 5 days of treatment ]
    The infection was completely resolved after 5 days of treatment (patients without infection symptoms and a negative blood culture).
  • Late clinical and microbiological response. [ Time Frame: Day 60 ]
    The infection was completely resolved at day 60 (patients without infection symptoms)
  • Mortality [ Time Frame: At 7,14 and 30 days ]
    Death for any reason
  • Length of hospital stay [ Time Frame: At 7,14 and 30 days ]
    Defined as the from admission to hospital discharge
  • Recurrences (relapse or reinfection) rate [ Time Frame: Day 60 after treatment ]
  • Safety of antibiotic treatment [ Time Frame: 60 days ]
    Gathering any related adverse event from the informed consent form signature up to 60 days
  • Impact of the study treatment on intestinal microbiota [ Time Frame: Screening, Day 7-14, Day 12-21, Day 30 ]
    Effect of study treatment on colonization of the intestinal tract with multi drug resistant gram negative bacilli


Original Secondary Outcome:

  • Early clinical and microbiological response. [ Time Frame: After 5 days of treatment ]
    The infection was completely resolved after 5 days of treatment (patients without infection symptoms and a negative blood culture).
  • Late clinical and microbiological response. [ Time Frame: Day 60 ]
    The infection was completely resolved at day 60 (patients without infection symptoms)
  • Mortality [ Time Frame: At 7,14 and 30 days ]
    Death for any reason
  • Length of hospital stay [ Time Frame: At 7,14 and 30 days ]
    Defined as the from admission to hospital discharge
  • Recurrences (relapse or reinfection) rate [ Time Frame: Day 30 after treatment ]
  • Safety of antibiotic treatment [ Time Frame: 60 days ]
    Gathering any related adverse event from the informed consent form signature up to 60 days
  • Impact of the study treatment on intestinal microbiota [ Time Frame: Screening, Day 7-14, Day 12-21, Day 30 ]
    Effect of study treatment on colonization of the intestinal tract with multi drug resistant gram negative bacilli


Information By: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Dates:
Date Received: April 1, 2016
Date Started: October 2016
Date Completion: May 2019
Last Updated: December 9, 2016
Last Verified: December 2016