Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae
NCT ID: NCT02795949
Last Updated: 2020-07-17
Study Results
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Basic Information
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COMPLETED
PHASE3
344 participants
INTERVENTIONAL
2016-10-31
2020-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Antipseudomonal beta-lactam antibiotic
1. Ampicillin 2g IV/6h
2. Trimethoprim/sulfamethoxazole 160/800 mg IV/8 -12h
3. Cefuroxime 750-1000 mg IV/8h
4. Cefotaxime 1-2g IV/8h ó ceftriaxone 1 g/12-24h
5. Amoxicillin/clavulanate 1000/125 mg IV/8h
6. Ciprofloxacin 400 mg IV/12h
7. Ertapenem 1-2g/24h.
Antipseudomonal beta-lactam antibiotic
Pharmaceutical form: solution for infusion
De-escalation(short-spectrum antibiotic)
* Piperacillin/tazobactam 4/0.5 g IV/8h
* Meropenem 1-2 g IV/8h
* Imipenem 0.5 g IV/6h - 1g IV/6h
* Aztreonam 1-2 g IV/8h
* Ceftazidime 1-2 g IV/8h
* Cefepime 2 g IV/8-12h
De-escalation(short-spectrum antibiotic)
Pharmaceutical form: solution for infusion
Interventions
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Antipseudomonal beta-lactam antibiotic
Pharmaceutical form: solution for infusion
De-escalation(short-spectrum antibiotic)
Pharmaceutical form: solution for infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Active empiric treatment with antipseudomonal betalactamic at 48 hours from the symptoms of sepsis and the blood culture.The patient could have received any other type of antibiotic therapy up to 24 hours after blood extraction.
3. Microorganism susceptible at least one treatment from the experimental arm.
4. Patients with intravenous treatment at least 3 days from the randomization o 5 days from the initial blood culture.
5. Patients to sign the informed consent form.
Exclusion Criteria
2. Pregnancy or lactation period.
3. To isolate the Extended-spectrum β-lactamases producing Enterobacteriaceae
4. Late randomization \>48 hours after the enterobacteriaceae blood culture´s identification
5. Severe neutropenic (\< 500 céls/mm3) at the randomization.
6. Treatment of infection \> 28 days (endocarditis and osteomyelitis) or meningitis.
18 Years
90 Years
ALL
No
Sponsors
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Spanish Network for Research in Infectious Diseases
OTHER
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Luis Eduardo Lopez Cortes, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitary Hospital Virgen Macarena
Locations
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Cruces Hospital
Barakaldo, Basque Country, Spain
Jerez de la Frontera Hospital
Jerez de la Frontera, Cádiz, Spain
La Línea de La Concepción Hospital
La Línea de la Concepción, Cádiz, Spain
University Hospital Donostia
Donostia / San Sebastian, Gipúzcoa, Spain
San Juan de Dios del Aljarafe Hospital
Bormujos, Sevilla, Spain
La Coruña Hospital
A Coruña, , Spain
University General Hospital of Alicante
Alicante, , Spain
University Hospital Mutua de Tarrasa
Barcelona, , Spain
University Hospital of Bellvitge
Barcelona, , Spain
University Hospital Puerta del Mar
Cadiz, , Spain
Puerto Real Hospital
Cadiz, , Spain
Universitary Hospital of Leon
León, , Spain
University Hospital La Princesa
Madrid, , Spain
University Hospital La Paz
Madrid, , Spain
Universitary Hospital of Orense
Ourense, , Spain
Son Espases Hospital
Palma de Mallorca, , Spain
University Clinic of Navarra
Pamplona, , Spain
University Hospital Marqués de Valdecilla
Santander, , Spain
University Hospital Virgen Macarena
Seville, , Spain
Universitary Hospital of Vigo
Vigo, , Spain
University Hospital of Zaragoza
Zaragoza, , Spain
Countries
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References
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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.
Related Links
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Spanish Network for Research in Infectious Diseases (Red Española de Investigación en Patología Infecciosa)
Other Identifiers
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SIMPLFY
Identifier Type: -
Identifier Source: org_study_id
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