Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae
- Conditions
- Enterobacteriaceae Infections
- Interventions
- Drug: Antipseudomonal beta-lactam antibioticDrug: De-escalation(short-spectrum antibiotic)
- Registration Number
- NCT02795949
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
- ≥18 years old hospitalized patients with bacteremia from any source with isolation of an enterobacteria in blood cultures.
- 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.
- Microorganism susceptible at least one treatment from the experimental arm.
- Patients with intravenous treatment at least 3 days from the randomization o 5 days from the initial blood culture.
- Patients to sign the informed consent form.
- Palliative care or life expectance < 90 days.
- Pregnancy or lactation period.
- To isolate the Extended-spectrum β-lactamases producing Enterobacteriaceae
- Late randomization >48 hours after the enterobacteriaceae blood culture´s identification
- Severe neutropenic (< 500 céls/mm3) at the randomization.
- Treatment of infection > 28 days (endocarditis and osteomyelitis) or meningitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antipseudomonal beta-lactam antibiotic 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. De-escalation(short-spectrum antibiotic) 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
- Primary Outcome Measures
Name Time Method Clinical cure at day 3-5 after treatment. 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.
- Secondary Outcome Measures
Name Time Method Late clinical and microbiological response. Day 60 The infection was completely resolved at day 60 (patients without infection symptoms)
Treatment duration. It is not allowed treatment duration more than 28 days Evaluate the study treatment duration.
Early clinical and microbiological response. After 5 days of treatment The infection was completely resolved after 5 days of treatment (patients without infection symptoms and a negative blood culture).
Mortality At 7,14 and 30 days Death for any reason
Length of hospital stay At 7,14 and 30 days Defined as the from admission to hospital discharge
Impact of the study treatment on intestinal microbiota 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
Secondary infections. 60 days Evaluate the development of secondary infections other than the initial bacteremia.
Safety of antibiotic treatment 60 days Gathering any related adverse event from the informed consent form signature up to 60 days
Recurrences (relapse or reinfection) rate Day 60 after treatment
Trial Locations
- Locations (21)
Son Espases Hospital
🇪🇸Palma de Mallorca, Spain
University Hospital Donostia
🇪🇸San Sebastian, Gipúzcoa, Spain
University Hospital of Bellvitge
🇪🇸Barcelona, Spain
Cruces Hospital
🇪🇸Baracaldo, País Vasco, Spain
La Coruña Hospital
🇪🇸La Coruña, Spain
San Juan de Dios del Aljarafe Hospital
🇪🇸Bormujos, Sevilla, Spain
Universitary Hospital of Leon
🇪🇸León, Spain
University Hospital La Princesa
🇪🇸Madrid, Spain
University Clinic of Navarra
🇪🇸Pamplona, Spain
Universitary Hospital of Orense
🇪🇸Orense, Spain
University Hospital La Paz
🇪🇸Madrid, Spain
Universitary Hospital of Vigo
🇪🇸Vigo, Spain
University Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Puerto Real Hospital
🇪🇸Cádiz, Spain
University Hospital Virgen Macarena
🇪🇸Seville, Spain
University Hospital Marqués de Valdecilla
🇪🇸Santander, Spain
University Hospital Mutua de Tarrasa
🇪🇸Barcelona, Spain
University General Hospital of Alicante
🇪🇸Alicante, Spain
University Hospital of Zaragoza
🇪🇸Zaragoza, Spain
La Línea de La Concepción Hospital
🇪🇸La Línea de La Concepción, Cádiz, Spain
Jerez de la Frontera Hospital
🇪🇸Jerez de la Frontera, Cádiz, Spain