Adaptación en las UCI de las recomendaciones de los proyectos ZERO durante la pandemia por SARS-CoV-2 / No disponible

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Daptomycin plus fosfomycin versus daptomycin monotherapy in treating MRSA: protocol of a multicentre, randomised, phase III trial.

INTRODUCTION: 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. METHODS AND ANALYSIS: A multicentre open-label, randomised phase III study. Adult patients hospitalised with MRSA bacteraemia will be randomly assigned (1:1) to group 1: daptomycin 10 mg/kg/24 h intravenous; or group 2: daptomycin 10 mg/kg/24 h intravenous plus fosfomycin 2 gr/6 g 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 72 h 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 (α:0.05, ß: 0.2). Statistical analysis will be based on intention to treat, as well as per protocol and safety analysis. ETHICS AND DISSEMINATION: 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 12 months of the completion of the study. TRIAL REGISTRATION NUMBER: NCT01898338.

Antibióticos nebulizados. ¿Una opción adecuada para el tratamiento de la infección respiratoria relacionada con la ventilación mecánica? / Nebulized antibiotics. An adequate option for treating ventilator-associated respiratory infection?

La traqueobronquitis asociada a la ventilación mecánica (TAVeM) es una complicación frecuente en los pacientes críticos. El 90% de quienes la desarrollan, reciben tratamiento antibiótico (ATB) de amplio espectro, sin que exista una fuerte evidencia de su impacto favorable. El uso de ATB nebulizados podría ser una opción válida de tratamiento, si se pretende disminuir el uso de ATB sistémico y la presión de selección sobre la flora local. Diferentes estudios sugieren, que con una técnica adecuada de nebulización, se pueden asegurar elevados niveles del ATB aún en áreas de consolidación pulmonar y obtener curación clínica y microbiológica. Nuevos estudios son necesarios para valorar adecuadamente el impacto del tratamiento con ATB nebulizados sobre la aparición de resistencias (AU)

Ventilator-associated tracheobronchitis (VAT) is a frequent complication in critical patients. The 90% of those who develop it receive broad-spectrum antibiotic (ATB) treatment, without any strong evidence of its favorable impact. The use of nebulized ATB could be a valid treatment option, to reduce the use of systemic ATB and the pressure of selection on the local flora. Several studies suggest that an adequate nebulization technique can ensure high levels of ATB even in areas of lung consolidation, and to obtain clinical and microbiological cure. New studies are needed to properly assess the impact of treatment with nebulized ATB on the emergence of resistance (AU)

Nebulized antibiotics. An adequate option for treating ventilator-associated respiratory infection?

Ventilator-associated tracheobronchitis (VAT) is a frequent complication in critical patients. The 90% of those who develop it receive broad-spectrum antibiotic (ATB) treatment, without any strong evidence of its favorable impact. The use of nebulized ATB could be a valid treatment option, to reduce the use of systemic ATB and the pressure of selection on the local flora. Several studies suggest that an adequate nebulization technique can ensure high levels of ATB even in areas of lung consolidation, and to obtain clinical and microbiological cure. New studies are needed to properly assess the impact of treatment with nebulized ATB on the emergence of resistance.

[Recommendations of the Infectious Diseases Work Group (GTEI) of the Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC) and the Infections in Critically Ill Patients Study Group (GEIPC) of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) for the diagnosis and treatment of influenza A/H1N1 in seriously ill adults admitted to the Intensive Care Unit]. / Recomendaciones del Grupo de Trabajo Enfermedades Infecciosas (GTEI) de la Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC) y el Grupo de Estudio de Infecciones en el Paciente Crítico (GEIPC) de la Sociedad Española de Enfermedades Infecciosas y Microbiología clínica (SEIMC) para el diagnóstico y tratamiento de la gripe A/H1N1 en pacientes adultos graves hospitalizados en las Unidades de Cuidados Intensivos.

The diagnosis of influenza A/H1N1 is mainly clinical, particularly during peak or seasonal flu outbreaks. A diagnostic test should be performed in all patients with fever and flu symptoms that require hospitalization. The respiratory sample (nasal or pharyngeal exudate or deeper sample in intubated patients) should be obtained as soon as possible, with the immediate start of empirical antiviral treatment. Molecular methods based on nucleic acid amplification techniques (RT-PCR) are the gold standard for the diagnosis of influenza A/H1N1. Immunochromatographic methods have low sensitivity; a negative result therefore does not rule out active infection. Classical culture is slow and has low sensitivity. Direct immunofluorescence offers a sensitivity of 90%, but requires a sample of high quality. Indirect methods for detecting antibodies are only of epidemiological interest. Patients with A/H1N1 flu may have relative leukopenia and elevated serum levels of LDH, CPK and CRP, but none of these variables are independently associated to the prognosis. However, plasma LDH> 1500 IU/L, and the presence of thrombocytopenia <150 x 10(9)/L, could define a patient population at risk of suffering serious complications. Antiviral administration (oseltamivir) should start early (<48 h from the onset of symptoms), with a dose of 75 mg every 12h, and with a duration of at least 7 days or until clinical improvement is observed. Early antiviral administration is associated to improved survival in critically ill patients. New antiviral drugs, especially those formulated for intravenous administration, may be the best choice in future epidemics. Patients with a high suspicion of influenza A/H1N1 infection must continue with antiviral treatment, regardless of the negative results of initial tests, unless an alternative diagnosis can be established or clinical criteria suggest a low probability of influenza. In patients with influenza A/H1N1 pneumonia, empirical antibiotic therapy should be provided due to the possibility of bacterial coinfection. A beta-lactam plus a macrolide should be administered as soon as possible. The microbiological findings and clinical or laboratory test variables may decide withdrawal or not of antibiotic treatment. Pneumococcal vaccination is recommended as a preventive measure in the population at risk of suffering severe complications. Although the use of moderate- or low-dose corticosteroids has been proposed for the treatment of influenza A/H1N1 pneumonia, the existing scientific evidence is not sufficient to recommend the use of corticosteroids in these patients. The treatment of acute respiratory distress syndrome in patients with influenza A/H1N1 must be based on the use of a protective ventilatory strategy (tidal volume <10 ml / kg and plateau pressure <35 mmHg) and positive end-expiratory pressure set to high patient lung mechanics, combined with the use of prone ventilation, muscle relaxation and recruitment maneuvers. Noninvasive mechanical ventilation cannot be considered a technique of choice in patients with acute respiratory distress syndrome, though it may be useful in experienced centers and in cases of respiratory failure associated with chronic obstructive pulmonary disease exacerbation or heart failure. Extracorporeal membrane oxygenation is a rescue technique in refractory acute respiratory distress syndrome due to influenza A/H1N1 infection. The scientific evidence is weak, however, and extracorporeal membrane oxygenation is not the technique of choice. Extracorporeal membrane oxygenation will be advisable if all other options have failed to improve oxygenation. The centralization of extracorporeal membrane oxygenation in referral hospitals is recommended. Clinical findings show 50-60% survival rates in patients treated with this technique. Cardiovascular complications of influenza A/H1N1 are common. Such problems may appear due to the deterioration of pre-existing cardiomyopathy, myocarditis, ischemic heart disease and right ventricular dysfunction. Early diagnosis and adequate monitoring allow the start of effective treatment, and in severe cases help decide the use of circulatory support systems. Influenza vaccination is recommended for all patients at risk. This indication in turn could be extended to all subjects over 6 months of age, unless contraindicated. Children should receive two doses (one per month). Immunocompromised patients and the population at risk should receive one dose and another dose annually. The frequency of adverse effects of the vaccine against A/H1N1 flu is similar to that of seasonal flu. Chemoprophylaxis must always be considered a supplement to vaccination, and is indicated in people at high risk of complications, as well in healthcare personnel who have been exposed.

Pautas de tratamiento antibiótico empírico de las infecciones intraabdominales / Guidelines for empiric antibiotic therapy in intra-abdominal infections

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Pautas de tratamiento antibiótico empírico de las infecciones intraabdominales / Guideliness for the empirical antibiotic treatment of intraabdominal infections

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International Conference for the Development of Consensus on the Diagnosis and Treatment of Ventilator-associated Pneumonia.

Ventilator-associated pneumonia (VAP) is an important health problem that still generates great controversy. A consensus conference attended by 12 researchers from Europe and Latin America was held to discuss strategies for the diagnosis and treatment of VAP. Commonly asked questions concerning VAP management were selected for discussion by the participating researchers. Possible answers to the questions were presented to the researchers, who then recorded their preferences anonymously. This was followed by open discussion when the results were known. In general, peers thought that early microbiological examinations are warranted and contribute to improving the use of antibiotherapy. Nevertheless, no consensus was reached regarding choices of antimicrobial agents or the optimal duration of therapy. Piperacillin/tazobactam was the preferred choice for empiric therapy, followed by a cephalosporin with antipseudomonal activity and a carbapenem. All the peers agreed that the pathogens causing VAP and multiresistance patterns in their ICUs were substantially different from those reported in studies in the United States. Pathogens and multiresistance patterns also varied from researcher to researcher inside the group. Consensus was reached on the importance of local epidemiology surveillance programs and on the need for customized empiric antimicrobial choices to respond to local patterns of pathogens and susceptibilities.

Efficacy and tolerability of piperacillin/tazobactam versus ceftazidime in association with amikacin for treating nosocomial pneumonia in intensive care patients: a prospective randomized multicenter trial.

OBJECTIVE: To compare clinical and bacteriological efficacy as well as tolerability of two regimens of broad-spectrum antibiotics (ceftazidime versus piperacillin/tazobactam) combined with amikacin in the treatment of nosocomial pneumonia in intensive care patients. DESIGN: Open label, prospective, multicenter, and randomized phase III clinical trial. SETTING: Medical or surgical intensive care units (ICUs) of nine acute-care teaching hospitals in Spain. PATIENTS AND PARTICIPANTS: One hundred and twenty-four ICU patients with nosocomial pneumonia and requiring mechanical ventilation were included. They were randomized to receive amikacin (15 mg/day divided into two doses) combined with either piperacillin (4 g every 6 h) and tazobactam (0.5 g every 6 h) (n = 88) or ceftazidime (2 g every 8 h) (n = 36). MEASUREMENTS AND RESULTS: The causative pathogen was determined in 60.2% of patients in the group of amikacin plus piperacillin/tazobactam and in 76.9% in the group of amikacin plus ceftazidime. A total of 94 bacterial organisms were isolated among which gram-negative bacilli predominated, Pseudomonas aeruginosa being the most frequent. Clinical response at the end of antibiotic therapy was considered satisfactory (cure and/or improvement) in 63.9% of patients in the amikacin plus piperacillin/tazobactam group and in 61.5% in the amikacin plus ceftazidime (odds ratio 1.1; 95% confidence interval 0.44-2.75). Eradication or presumptive eradication rates for each pathogen and for either gram-negative or gram-positive bacteria were similar in both antibiotic combinations (odds ratio 1.2; 95% confidence interval 0.39-3.66). A total of 21 adverse effects (23.9%) occurred in the amikacin plus piperacillin and tazobactam group and six (16.7%) in the amikacin plus ceftazidime group, thrombocytosis, renal dysfunction, and hepatic cytolysis being the most common. The efficacy and tolerability of the two therapeutic regimens were similar not only in the whole study population, but also in the subset of P. aeruginosa-related pneumonia (odds ratio 1; 95% confidence interval 0.08-13.37). CONCLUSIONS: Amikacin associated with either ceftazidime or piperacillin and tazobactam has shown comparable efficacy and tolerability in the treatment of ICU patients with nosocomial pneumonia.

Antibacterial treatment of invasive mechanical ventilation-associated pneumonia.

Patients admitted to intensive care units (ICU) are at higher risk of acquiring nosocomial infections than patients in other hospital areas. This is the consequence of both a greater severity of illness with its implications (manipulation, invasiveness) and crossed infection from reservoirs inside the ICU. The most frequent nosocomial infection is invasive ventilation-associated pneumonia (VAP) which leads to an important increase in morbidity and mortality. The most important aetiological agents in VAP are bacteria, with a marked predominance of Staphylococcus aureus and Pseudomonas aeruginosa. These aetiologies may be different depending upon the type of ICU (medical, surgical, coronary) or the presence of certain risk factors (duration of mechanical ventilation before onset of pneumonia, previous exposure to antibacterials). Susceptibilities of the aetiological agents to antibacterials may also vary according to the type of ICU and over time. Data from global studies show an increase in multiresistant bacteria but these data may not be applied to a local ICU. The availability of accurate and updated information on the most frequently encountered organisms in each ICU and their susceptibilities is very important in order to provide the most adequate treatment. A controversial issue is the selection of antibacterials. According to the latest evidence the most adequate approach is a prompt administration of empirical treatment. Based on knowledge of bacterial flora in our own ICU, the choice of an adequate therapeutic regimen will decrease both morbidity and mortality. A second issue is monotherapy versus combined therapy. The most common recommendation, with a few exceptions, is to use combined therapy until microbiological results are received. Another controversy is the choice of antibacterials in the combined regimen. The most commonly recommended combination is that of a beta-lactam with an aminoglycoside, except in early-onset pneumonia without risk factors. The use of monotherapy with a cefalosporin without antipseudomonal activity or amoxicillin-clavulanic acid is the recommended regimen. Treatment should be modified based on microbiological results. There are no well documented recommendations on the prophylactic duration of treatment and it must be based on the aetiological agent and the clinical course. In summary treatment of VAP must be prompt, empirical and combined (beta-lactam plus aminoglycoside ). However, the choice of the antibacterial regimen should follow local guidelines of treatment based upon the knowledge of the most frequently isolated bacterial flora and their susceptibilities in different clinical settings.