Hospital Universitari Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Santa Creu i Sant Pau

Barcelona, Spain
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PubMed | Hospital Universitari Of Terrassa, Hospital Universitari Of Bellvitge Idibell, Hospital Universitario Virgen Of Las Nieves, Hospital Universitario 12 Of Octubre and 15 more.
Type: Clinical Trial, Phase III | Journal: BMJ open | Year: 2015

Despite the availability of new antibiotics such as daptomycin, methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia continues to be associated with high clinical failure rates. Combination therapy has been proposed as an alternative to improve outcomes but there is a lack of clinical studies. The study aims to demonstrate that combination of daptomycin plus fosfomycin achieves higher clinical success rates in the treatment of MRSA bacteraemia than daptomycin alone.A multicentre open-label, randomised phase III study. Adult patients hospitalised with MRSA bacteraemia will be randomly assigned (1:1) to group 1: daptomycin 10mg/kg/24h intravenous; or group 2: daptomycin 10mg/kg/24h intravenous plus fosfomycin 2gr/6g intravenous. The main outcome will be treatment response at week 6 after stopping therapy (test-of-cure (TOC) visit). This is a composite variable with two values: Treatment success: resolution of clinical signs and symptoms (clinical success) and negative blood cultures (microbiological success) at the TOC visit. Treatment failure: if any of the following conditions apply: (1) lack of clinical improvement at 72h or more after starting therapy; (2) persistent bacteraemia (positive blood cultures on day 7); (3) therapy is discontinued early due to adverse effects or for some other reason based on clinical judgement; (4) relapse of MRSA bacteraemia before the TOC visit; (5) death for any reason before the TOC visit. Assuming a 60% cure rate with daptomycin and a 20% difference in cure rates between the two groups, 103 patients will be needed for each group (:0.05, : 0.2). Statistical analysis will be based on intention to treat, as well as per protocol and safety analysis.The protocol was approved by the Spanish Medicines and Healthcare Products Regulatory Agency (AEMPS). The sponsor commits itself to publishing the data in first quartile peer-review journals within 12months of the completion of the study.NCT01898338.


Bermejo F.,Hospital Universitario Of Fuenlabrada | Garrido E.,Hospital Universitario Ramon y Cajal | Chaparro M.,Hospital Universitario La Paz | Chaparro M.,CIBER ISCIII | And 11 more authors.
Inflammatory Bowel Diseases | Year: 2012

Background: Management of abdominal abscesses (AA) in Crohn's disease (CD) always includes antibiotics, and some type of drainage is added according to the response and other considerations. Our aim was to assess the efficacy of different therapeutic approaches to spontaneous AA in CD. Methods: All cases of AA in CD were identified from the databases of five university hospitals. Postoperative cases were excluded. Therapeutic success was defined as abscess resolution and nonreappearance within 1 year of follow-up. Results: We identified 128 cases in 2236 patients (cumulative incidence 5.7%). Initial therapy included medical therapy with antibiotics alone (42.2%), antibiotics plus percutaneous drainage (23.4%), and antibiotics plus surgical drainage (34.4%). The highest final efficacy corresponded to surgery (91%) as compared with antibiotic therapy alone (63%) or percutaneous drainage (30%). Failure of initial therapy was predicted by immunomodulators at diagnosis (odds ratio [OR] 8.45; 95% confidence interval [CI] 1.16-61.5; P = 0.03), fistula detectable in imaging techniques (OR 5.43; 95% CI 1.18-24.8; P = 0.02), and abscess size (OR 1.65; 95% CI 1.07-2.54; P = 0.02) only for patients treated with antibiotic therapy alone. Percutaneous drainage was associated with 19% of complications (enterocutaneous fistulas 13%); surgery was associated with 13% of postoperative complications (enterocutaneous fistulas 7.7%). Following abscess resolution, 60% of patients were started on thiopurines, 9% on biologics, and in 31% baseline therapy was not modified. Conclusions: Management of spontaneous AA in CD with antibiotics alone seems to be a good option for small abscesses, especially those without associated fistula and appearing in immunomodulator-naïve patients. Surgery offers better results in the remaining clinical settings, although percutaneous drainage can avoid operative treatment in some cases. Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.


Bermudo C.,Hospital Universitario Virgen Macarena | Cardenas M.C.,Hospital Clinico San Carlos | Cortes M.,Hospital Universitari Santa Creu i Sant Pau | Fernandez M.,Hospital Carmen y Severo Ochoa | And 6 more authors.
Revista del Laboratorio Clinico | Year: 2012

Background: Measurement of immunoglobulin free light chains provides relevant clinical information for the diagnosis, prognosis and monitoring of multiple myeloma (MM) and monoclonal gammopathies of undetermined significance (MGUS). We evaluated the negative predictive value (NPV) of a serum free kappa to lambda (κ/λ) ratio included within the described reference range (0.26-1.65) and also set cut-off points for the ratio in order to ensure a 100% NPV. Methods: Serum concentration of free light chains was measured by nephelometry in 157 individuals diagnosed as having MM or MGUS, and the free κ/λ ratio was calculated. Results: The area under the curve of the free κ/λ ratio was 0.885 in the kappa type gammopathies subgroup, and 0.879 for the lambda subgroup. The NPV for a free κ/λ ratio between 0.26 and 1.65 was 92%. Using cut-off points of 0.36 and 1.0 for the ratio, achieved a 100% NPV. Conclusions: A change from the cut-off point 0.26-1.65 to 0.36-1.0 for the free κ/λ ratio could be useful in order to avoid performing a bone marrow aspirate in patients with MGUS clinical and laboratory criteria. © 2011 AEBM, AEFA y SEQC.


Echeverria P.,Hospital Universitari Germans Trias i Pujol | Echeverria P.,Autonomous University of Barcelona | Domingo P.,Hospital Universitari Santa Creu i Sant Pau | Llibre J.-M.,Hospital Universitari Germans Trias i Pujol | And 18 more authors.
BioMed Research International | Year: 2014

Background. There are conflicting data on the prevalence of coronary events and the quality of the management of modifiable cardiovascular risk factors (CVRF) in HIV-infected patients. Methods. We performed a retrospective descriptive study to determine the prevalence of coronary events and to evaluate the management of CVRF in a Mediterranean cohort of 3760 HIV-1-infected patients from April 1983 through June 2011. Results. We identified 81 patients with a history of a coronary event (prevalence 2.15%); 83% of them suffered an acute myocardial infarction. At the time of the coronary event, CVRF were highly prevalent (60.5% hypertension, 48% dyslipidemia, and 16% diabetes mellitus). Other CVRF, such as smoking, hypertension, lack of exercise, and body mass index, were not routinely assessed. After the coronary event, a significant decrease in total cholesterol P = 0.025 and LDL-cholesterol P = 0.004 was observed. However, the percentage of patients who maintained LDL-cholesterol > 100 mg/dL remained stable (from 46% to 41%, P = 0.103). Patients using protease inhibitors associated with a favorable lipid profile increased over time P = 0.028. Conclusions. The prevalence of coronary events in our cohort is low. CVRF prevalence is high and their management is far from optimal. More aggressive interventions should be implemented to diminish cardiovascular risk in HIV-infected patients. © 2014 Patricia Echeverría et al.


PubMed | Hospital Universitari Santa Creu i Sant Pau and Autonomous University of Barcelona
Type: | Journal: BioMed research international | Year: 2014

There are conflicting data on the prevalence of coronary events and the quality of the management of modifiable cardiovascular risk factors (CVRF) in HIV-infected patients.We performed a retrospective descriptive study to determine the prevalence of coronary events and to evaluate the management of CVRF in a Mediterranean cohort of 3760 HIV-1-infected patients from April 1983 through June 2011.We identified 81 patients with a history of a coronary event (prevalence 2.15%); 83% of them suffered an acute myocardial infarction. At the time of the coronary event, CVRF were highly prevalent (60.5% hypertension, 48% dyslipidemia, and 16% diabetes mellitus). Other CVRF, such as smoking, hypertension, lack of exercise, and body mass index, were not routinely assessed. After the coronary event, a significant decrease in total cholesterol (P = 0.025) and LDL-cholesterol (P = 0.004) was observed. However, the percentage of patients who maintained LDL-cholesterol > 100 mg/dL remained stable (from 46% to 41%, P = 0.103). Patients using protease inhibitors associated with a favorable lipid profile increased over time (P = 0.028).The prevalence of coronary events in our cohort is low. CVRF prevalence is high and their management is far from optimal. More aggressive interventions should be implemented to diminish cardiovascular risk in HIV-infected patients.

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