Randomized, multicenter, open, controlled clinical trial, to demonstrate the non-inferiority of reduced antibiotic treatment against the treatment of a broad spectrum in treating patients with bacteremia due to enterobacter.
- Conditions
- Monomicrobial bacteremia from any source due to EnterobactericiaeMedDRA version: 18.1Level: PTClassification code 10058857Term: Enterobacter bacteraemiaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-004219-19-ES
- Lead Sponsor
- FISEVI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 344
1) ?18 years old hospitalized patients with bacteremia from any source with isolation of an enterobacteria in blood cultures.
2) Active empiric treatment with antipseudomonic betalactamic at 48 hours from the symptoms of sepsis and the blood culture.
3) Microorganism susceptible at least one treatment from the experimental arm.
4) Patients with intravenous treatment at least 5 days.
5) Patients to sign the informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
1 )Palliative care or life expectance < 90 days.
2) Pregnancy or lactation period.
3) To isolate the Extended-spectrum ?-lactamases producing Enterobactericiae
4) Late randomization >48 hours after the enterobactericiae blood culture´s identification
5) Severe neutropenic (< 500 céls/mm3) at the randomization.
6) Treatment of infection > 28 days (endocarditis and osteomyelitis) or meningitis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the clinical non-inferiority of short-spectrum antibiotic treatment compared to extended-spectrum treatment with antipseudomonic betalactamic using clinical cure at 14 days;Secondary Objective: 1)To evaluate the clinical response at 5 days and at 30 days, mortality until to 30 days, lenght of hospital stay and recurrences of both treatment strategies directed.<br>2) To evaluate the number of days of antibiotic treatment with a beta-lactam avoided antipseudomonal<br>3) Safety of antiotic treatment included in the protocol.<br>4) To examine a group of patients about the colonization by multiresistant gram-negative bacilli, and to evaluate the duration of treatment at 30 day after bacteremia diagnosis.;Primary end point(s): Clinical cure at 14 days.;Timepoint(s) of evaluation of this end point: 14 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Early clinical and microbiological response at 5 days of treatment.<br>2) Late clinical and microbiological response at 30 days.<br>3) Mortality at 7,14 and 30 days and lenght of hospital stay<br>4) Recurrences rate at 30 days.<br>5) Rate of adverse reactions. Effect of the rectal colonization of MDRGNB (Multi drug resistant Gram negative bacilli).;Timepoint(s) of evaluation of this end point: 1) 5 days<br>2) 30 days<br>3) 7,14 y 30 days.<br>4) 30 days