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

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.

Timeline

Start

2016-10

Primary completion

2020-01

Completion

2020-01

Publications

• Lopez-Cortes LE, Delgado-Valverde M, Moreno-Mellado E, Goikoetxea Aguirre J, Guio Carrion L, Blanco Vidal MJ, Lopez Soria LM, Perez-Rodriguez MT, Martinez Lamas L, Arnaiz de Las Revillas F, Arminanzas C, Ruiz de Alegria-Puig C, Jimenez Aguilar P, Del Carmen Martinez-Rubio M, Saez-Bejar C, de Las Cuevas C, Martin-Aspas A, Galan F, Yuste JR, Leiva-Leon J, Bou G, Capon Gonzalez P, Boix-Palop L, Xercavins-Valls M, Goenaga-Sanchez MA, Anza DV, Caston JJ, Rufian MR, Merino E, Rodriguez JC, Loeches B, Cuervo G, Guerra Laso JM, Plata A, Perez Cortes S, Lopez Mato P, Sierra Monzon JL, Rosso-Fernandez C, Bravo-Ferrer JM, Retamar-Gentil P, Rodriguez-Bano J; SIMPLIFY study group. Efficacy and safety of a structured de-escalation from antipseudomonal beta-lactams in bloodstream infections due to Enterobacterales (SIMPLIFY): an open-label, multicentre, randomised trial. Lancet Infect Dis. 2024 Apr;24(4):375-385. doi: 10.1016/S1473-3099(23)00686-2. Epub 2024 Jan 9.
• Lopez-Cortes LE, Rosso-Fernandez C, Nunez-Nunez M, Lavin-Alconero L, Bravo-Ferrer J, Barriga A, Delgado M, Lupion C, Retamar P, Rodriguez-Bano J; SIMPLIFY Study Group. Targeted simplification versus antipseudomonal broad-spectrum beta-lactams in patients with bloodstream infections due to Enterobacteriaceae (SIMPLIFY): a study protocol for a multicentre, open-label, phase III randomised, controlled, non-inferiority clinical trial. BMJ Open. 2017 Jun 9;7(6):e015439. doi: 10.1136/bmjopen-2016-015439.

Drugs

Indications