Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae (SIMPLIFY)
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|ClinicalTrials.gov Identifier: NCT02795949|
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : July 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Enterobacteriaceae Infections||Drug: Antipseudomonal beta-lactam antibiotic Drug: De-escalation(short-spectrum antibiotic)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||344 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 With Bacteremia by Enterobacteriaceae|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
Experimental: Antipseudomonal beta-lactam antibiotic
Drug: Antipseudomonal beta-lactam antibiotic
Pharmaceutical form: solution for infusion
Active Comparator: De-escalation(short-spectrum antibiotic)
Drug: De-escalation(short-spectrum antibiotic)
Pharmaceutical form: solution for infusion
- 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.
- 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
- Treatment duration. [ Time Frame: It is not allowed treatment duration more than 28 days ]Evaluate the study treatment duration.
- Secondary infections. [ Time Frame: 60 days ]Evaluate the development of secondary infections other than the initial bacteremia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795949
|Principal Investigator:||Luis Eduardo Lopez Cortes, MD, PhD||Universitary Hospital Virgen Macarena|